Devices to treat nasal airways

ABSTRACT

A device is described for treating a nasal airway by modifying a property of a nasal tissue of or near a nasal valve of the airway, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in the nasal airway. Various embodiments include an elongate shaft, a bipolar radiofrequency delivery member extending from one end of the shaft, and a handle attached to the elongate shaft at an opposite end from the radiofrequency delivery member. The radiofrequency delivery member is sized to be inserted into a nose and configured to at least temporarily deform the nasal tissue and deliver radiofrequency energy. The radiofrequency delivery member includes two rows of protruding electrodes disposed on a tissue contact surface, and the device is configured to deliver radiofrequency energy from one row of electrodes to the other row of electrodes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/864,428, entitled “DEVICES TO TREAT NASAL AIRWAYS,” filed Sep. 24,2015, which is a continuation of U.S. patent application Ser. No.14/737,196, now U.S. Pat. No. 9,179,967, entitled “DEVICES TO TREATNASAL AIRWAYS,” filed Jun. 11, 2015, which is a continuation of U.S.patent application Ser. No. 14/607,639, now U.S. Pat. No. 9,179,964,entitled METHODS AND DEVICES TO TREAT NASAL AIRWAYS, filed Jan. 28,2015, which is a continuation of U.S. patent application Ser. No.14/026,922, now U.S. Pat. No. 8,986,301, entitled METHODS AND DEVICES TOTREAT NASAL AIRWAYS, filed Sep. 13, 2013, which is acontinuation-in-part of U.S. patent application Ser. No. 13/495,844, nowU.S. Pat. No. 8,936,594, entitled METHODS AND DEVICES TO TREAT NASALAIRWAYS, filed Jun. 13, 2012, which claims priority to U.S. ProvisionalPatent Application No. 61/603,864, filed on Feb. 27, 2012 and61/496,930, filed Jun. 14, 2011. The disclosures of all theabove-referenced patent applications are hereby incorporated byreference in their entireties herein.

FIELD OF THE INVENTION

This application relates generally to the field of medical devices andtreatments, and in particular to systems, devices and methods fortreating structures within the nose and upper airway to reduceresistance to airflow and/or change the pressure level in the nose,nasal cavities, and/or and nasal passages and thus improve airflowand/or the feeling and effects of nasal obstruction during breathingand/or reduce snoring.

DESCRIPTION OF THE RELATED ART

During respiration, the anatomy, shape, tissue composition andproperties of the human airway produce airflow resistance. The nose isresponsible for almost two thirds of this resistance. Most of thisresistance occurs in the anterior part of the nose, known as theinternal nasal valve, which acts as a flow-limiter. The external nasalvalve structure also causes resistance to nasal airflow. Effectivephysiological normal respiration occurs over a range of airflowresistances. However, excessive resistance to airflow can result inabnormalities of respiration that can significantly affect a patient'squality of life.

Inadequate nasal airflow can result from a number of conditions causingan inadequate cross sectional area of the nasal airway in the absence ofany collapse or movement of the cartilages and soft tissues of the nasalairway. These include deviation of the nasal septum, turbinateenlargement, mucosal swelling, excessive mucus production, and nasalvalve insufficiency, narrowing or collapse. No matter what the cause ofinadequate nasal airflow, the nasal valve area is still the site ofsignificant nasal airflow resistance. In more extreme cases, nasal valvedysfunction is a prevalent medical condition. Nasal valve collapse isoften due to weakness or malformation of cartilage structures of thenose.

Inadequate nasal airflow can also result from the movement of tissues ofthe nasal passage during respiration. The nasal passage may have normalanatomy and structure with a nasal passage cross-sectional area in thenormal range at rest or during expiration. On inspiration of air throughthe nose, the nasal tissues can move inward, reducing the crosssectional area of the nasal passage. This movement, sometimes callednasal valve collapse, can be caused by the reduction of pressure in thenose when air flows past the structure of the nose. This pressurereduction pulls the tissues of the nasal passage together, causing adynamic nasal passage cross sectional area reduction on inspiration.

The walls of the nasal passage are composed of various tissue types,including the mucosa, submucosa, basal membrane and cartilage. Themucosa, submucosa and basal membrane contain collagen, which gives thetissue structure and elasticity.

Cartilage is an avascular tissue composed of a specialized matrix ofcollagens, proteoglycans, and non-collagen proteins, in whichchondrocytes constitute the unique cellular component. Cartilage isspecialized connective tissue found in various locations throughout thebody. Cartilage basically consists of two components: water and aframework of structural macromolecules (matrix) that give the tissue itsform and function. The matrix is highly organized and composed ofcollagens, proteoglycans and noncollagenous proteins.

The interaction of water and the macromolecular framework gives thetissue its mechanical properties and thus its function. Up to 65%-80% ofthe wet weight of cartilage consists of water, and the rest is matrix,mainly collagens and proteoglycans. Chondrocytes are specialized cellsthat produce and maintain the extracellular matrix (ECM) of cartilage.The ECM makes up most of the tissue, where dense, covalently-linkedheterotypic collagen fibrils interact with a number of other specializedmatrix components.

The nasal valve was originally described by Mink in 1903. It is dividedinto external and internal portions. The external nasal valve is theexternal nasal opening formed by the columella at the base of theseptum, the nasal floor, and the nasal rim (the lower region of thenasal wall, also known as the caudal border of the lower lateralcartilage). The nasalis muscle dilates the external nasal valve portionduring inspiration.

The internal nasal valve, which accounts for the larger part of thenasal resistance, is located in the area of transition between the skinand respiratory epithelium. The internal nasal valve area is formed bythe nasal septum, the caudal border of the upper lateral cartilage(ULC), the head of the inferior turbinate, and the pyriform aperture andthe tissues that surround it.

The angle formed between the caudal border of the ULC and the nasalseptum is normally between about 10 degrees and about 15 degrees, asillustrated in FIG. 1. The internal nasal valve is usually the narrowestpart of the nasal airway and is responsible for more than two thirds ofthe resistance produced by the nose.

In 1894, Franke performed nasal-flow experiments in models and cadaversand found that whirl formation occurred near the head of the turbinateduring calm breathing. Mink developed this concept further in 1920,suggesting that the greatest area of resistance was in the limen nasi orthe union of the lobular cartilage and ULCs. In 1940, Uddstromer foundthat 70% of the resistance of the nose was produced in the internalnasal valve area, and the remaining 30% was due to the nasal fossa. VanDishoeck further investigated the mechanisms of the nasal valve in 1942,and in 1970, Bridger and Proctor wrote about a “flow-limiting segment”that included the limen nasi and the pyriform aperture. In 1972, Bachmanand Legler found the pyriform aperture to have the smallestcross-sectional area of the nasal airway. In 1983, Haight and Colecontinued the study of Bridger and Proctor and demonstrated that themaximal nasal resistance was localized near the pyriform aperture anddepended on engorgement of the head of the inferior turbinate. The nasalvalve and its functions are more fully described in Cole, “The FourComponents of the Nasal Valve,” American Journal of Rhinology, Vol. 17,No. 2, pp. 107-110 (2003). See also, Cole, “Biophysics of Nasal AirFlow: A Review,” American Journal of Rhinology, Vol. 14, No. 4, pp.245-249 (2000).

Because ventilation involves pressure changes, the nasal airways must bestable both at rest and under the negative pressures created duringquiet and forced inspiration. Proper airflow through the nasal airwaydepends on satisfactory structural stability (and/or resistance toconformational change resulting from pressure changes) of the upper andlower lateral cartilages and soft tissues respectively. Satisfactoryskeletal stability is present when the upper and lower lateralcartilages have sufficient structural stability to resist conformationalchanges resulting from air pressure changes. When either the skeletal orthe soft tissue component is congenitally deficient or has beencompromised by surgery or trauma, the patient experiences a conformationchange of the valves during inspiration, with resultant change in theairflow and/or pressure in the nasal airway. Normally, the upper lateralcartilages move, change shape, partially collapse and/or change nasalairway pressure with all ventilatory flow rates. Thus, even normal nasalvalves are affected by respiration. However, a patient with dynamicnasal valve dysfunction may have a nasal airway walls that inadequatelyresist the pressure changes and restrict airflow even during normalnasal breathing.

Inadequate nasal valve structural strength, stiffness or conformationcan be a consequence of previous surgery, trauma, aging, or primaryweakness of the upper lateral cartilage and is often symptomatic anddebilitating. As many as 13% of patients with chronic nasal obstructionhave some degree of nasal valve collapse. Of these patients, 88% haveunilateral collapse.

Poor nasal breathing and/or nasal congestion has profound effects on aperson's health and quality of life, which can be measured by validatedquestionnaires such as the NOSE score, as described in Stewart M G,Witsell D L, Smith T L, Weaver E M, Yueh B, and Hannley M T.,“Development and Validation of the Nasal Obstruction Symptom Evaluation(NOSE) Scale,” Otolaryngol Head Neck Surg 2004; 130:157-63.

Causes of inadequate nasal airflow and the structure of nasal valveinadequacy can be clinically detected by direct visualization(preferably with minimal disturbance so as not to alter the structure byvisualizing) or endoscopic examination. Alternatively, CT, Mill,ultrasound or other non-invasive imaging technologies may be employed.One method of evaluating the potential improvement in nasal airflow fromwidening the nasal valve area is the cottle test, which involves gentlypulling the skin of a patient's cheek laterally away from the nose withtwo fingers, thereby opening the internal nasal valve.

Existing methods of correcting nasal valve inadequacy include surgicallyrepositioning the upper lateral cartilage or adding structural grafts tosupport the lateral wall of the nose. Surgical structural enhancement ofthe valve can include the use of cartilage grafts and grafts made from anumber of materials. The most frequent methods surgically correctinternal nasal valve collapse and involve the use of spreader graftsplaced between the upper lateral cartilage and septum. Alternately,stents, spreaders or other devices may be implanted to reposition theULC. Invasive surgical and implant solutions carry substantial risk anddiscomfort.

External (non-implanted) nasal dilators, which are placed temporarilyand removed by the patient, are also available. Such external devicesare possibly placed on the outside surface of the nose, such as the“Breathe Right” strips, as shown for example in U.S. Pat. No. 5,533,499to Johnson, or similar devices taught by U.S. Pat. No. 7,114,495 toLockwood. Other devices may be temporarily placed in the nasal cavity(but not implanted in the nose), such as those taught in U.S. Pat. No.7,055,523 to Brown, and U.S. Pat. No. 6,978,781 to Jordan. However, suchdevices can be uncomfortable, unsightly, and require the patient toremove and replace the device on a periodic basis. These devices canalso cause skin irritation.

Poor nasal airflow can also occur in people with a structurally normalnasal and/or nasal valve anatomy, as well as a normal nasal passagecross-sectional area. The strength, structure and resistance to collapseof the nasal passage can also be normal in people with poor nasalairflow. People can have poor nasal airflow from other causes, includingdeviated septum, allergic rhinitis, non-allergic rhinitis, turbinatehyperplasia, nasal tip ptosis, and nasal polyposis. Whatever the cause,the tissues of the nasal valves are intimately involved in nasal airflowand nasal airflow inadequacy. Thus, there remains an unmet need in theart for non-invasive and minimally invasive methods and devices toimprove nasal airflow.

SUMMARY

Embodiments of the present application are directed to devices, systemsand methods for treating nasal airways. Such embodiments may be utilizedto improve breathing by decreasing airflow resistance or perceivedairflow resistance in the nasal airways. For example, the devices,systems and methods described herein may be utilized to reshape,remodel, strengthen, or change the properties of the tissues of thenose, including, but not limited to the skin, muscle, mucosa, submucosaand cartilage in the area of the nasal valves.

According to one aspect, a device for treating a patient's nasal airwayis provided. In one embodiment, the device comprises an energy deliveryelement sized to be inserted into a nose or to be delivered external toa nose. The energy delivery element is configured to deliver energy totissues within the nose and to reshape a region of the nose to a newconformation.

According to one embodiment, a device for treating a patient's nasalairway comprises an elongate shaft having a proximal end and a distalend. The device further comprises a handle at the proximal end of theelongate shaft. The device also comprises a treatment element at thedistal end of the elongate shaft. The treatment element is sized to beinserted into the nasal airway or to be delivered external to a nose.The treatment element is configured to reshape a region of the nose to anew conformation and comprises an electrode configured to deliverradiofrequency (RF) energy to the nasal tissue.

Other embodiments of devices for treating a patient's nasal airwayinclude devices that apply other types of treatment. For example, atreatment device may apply energy in the form selected from the groupconsisting of ultrasound, microwave, heat, radiofrequency, electrical,light and laser. The treatment device may also be configured to inject apolymerizing liquid or to deliver a cauterizing agent to nasal tissue.Other embodiments are described below.

The devices described herein may be configured to be positionedinternally within the nose, external to the nose, or both. Certainembodiments are configured to be delivered into one nostril, and otherembodiments are configured to be delivered into both nostrils. In someembodiments the device may comprise a reshaping element having a shapeconfigured to alter a conformation of a region of the nose to a newconformation. For embodiments utilizing an energy delivery element, thereshaping element may be a separate element from the energy deliveryelement, or the energy delivery element and the reshaping element may bepart of the same element. The energy delivery element and/or reshapingelement in one embodiment may have a convex shape to create a concavityin nasal tissue.

In embodiments utilizing energy delivery, a handle may be providedcomprising a button or other input control to active one or moreelectrodes. Electrodes may comprise one or more monopolar needles, oneor more monopolar plates, or one or more bipolar electrode pairs (whichmay also comprise one or more needles or plates). These electrodes maybe located in various locations, for example, inside the nasalpassageway, external to the nose or both. For example, when usingbipolar electrode pairs, a first electrode surface may be positionedinternal to the nose and a second electrode surface may be positionedexternal to the nose, so that the two electrode surfaces are positionedon opposite sides of nasal tissue.

The device of one energy delivery embodiment may comprise an adaptorconfigured to be connected to an energy source, such as an RF energysource. The device may also comprise a control system configured tocontrol the characteristics of energy applied to tissue. A thermocoupleor other sensor may be provided to measure a temperature near tissue orother tissue or device parameter.

In another aspect, a system is provided comprising a device as describedabove and further below in combination with one or more othercomponents. One such component may be an energy source, such as an RFenergy source. Another component may be a control system for controllingthe energy source and/or treatment device. In another embodiment, thedevice or system may comprise a cooling mechanism to cool desired tissuelocations while treatment is being applied. In monopolar electrodeembodiments, a grounding pad may also be provided as part of the system.Another system includes a positioning device that may be usedpre-treatment to determine the optimal device and positioning and/orother parameters for using the device to be treat to the nasal airway.

According to another aspect, a method of treating a patient's nasalairway is provided. In one embodiment, the method comprises alerting astructure, shape or conformation of one or more nasal structures in anarea of a nasal valve by applying a treatment sufficient to modify, byreshaping, tissue at or adjacent to the nasal valve.

According to one embodiment, a method of treating a patient's nasalairway comprises positioning a treatment element within the nasal airwayadjacent to nasal tissue to be treated. The treatment element comprisesone or more electrodes, such as described above and in further detailbelow. The method further comprises deforming the nasal tissue into adesired shape by pressing a surface of the treatment element against thenasal tissue to be treated. The method further comprises deliveringradiofrequency (RF) energy to the one or more electrodes to locally heatthe nasal tissue, wherein delivering RF energy while deforming the nasaltissue causes the nasal tissue to change shape. The method alsocomprises removing the treatment element from the nasal airway.

The methods, devices and systems described herein may be used to reshapetissue without a surgical incision or implant. In certain embodiments,the reshaping of tissue may be accomplished by ablating tissue. In otherembodiments, the reshaping of tissue is accomplished without ablation oftissue. In one embodiment, a treatment element is positioned within anasal passageway. The treatment element may be used to simultaneouslymechanically alter the shape of the internal or external nasal valve andapply treatment to tissue of the nose. The treatment applied maycomprise modifying a nasal structure in a manner that increases avolumetric airflow rate of air flowing from an exterior of the patient'sbody into the patient's nasopharynx without changing a shape of aninternal nasal valve, said modifying comprising modifying a mechanicalproperty of at least one nasal valve. A positioning element may be usedto determine a desired position of a treatment element before thetreatment element is delivered to the nasal tissue.

The treatment may involve delivering energy in the form selected fromthe group selected from the group consisting of ultrasound, microwave,heat, radiofrequency, electrical, light and laser. The nasal tissue tobe treated may be cooled prior to, during or after delivering energy.Delivering energy may comprise measuring a temperature near nasal tissueto be treated, and adjusting a level of energy delivered to the tissue.When RF or other types of energy are used, the energy may be deliveredto at least one of the nasal valve, tissue near the nasal valve, or theupper lateral cartilage of tissue. For example, RF energy or otherenergy may be delivered to the one or more electrodes for about 15seconds to about 1 minute. RF energy or other energy may be delivered toheat an area of tissue to a temperature of about 50 degrees Celsius toabout 70 degrees Celsius.

Other methods not utilizing energy delivery include injecting apolymerizing liquid, delivering a cauterizing agent, or otherembodiments described below.

Energy or treatment may be delivered for a sufficient period of time orin a sufficient quantity to cause a desired effect. For example, thetreatment may cause stress relaxation in the nasal tissue withoutweakening the tissue. The treatment may also be applied to injure atissue to be re-shaped.

In another aspect, a method of modifying at least one property of atleast one tissue of or near a nasal valve of a nose, without using asurgical incision or an implant, to decrease airflow resistance orperceived airflow resistance in a nasal airway, may involve: contactinga treatment element of a treatment device with the at least one tissueinside the nasal airway, with sufficient force to at least temporarilydeform the at least one tissue; applying energy to, or removing energyfrom, the at least one tissue, using the treatment element; and removingthe treatment element from the nostril.

In some embodiments, the treatment element may have a convex shape, suchthat contacting the treatment element against the at least one tissue atleast temporarily deforms the tissue into a concave shape. In someembodiments, contacting the treatment element with the tissue causes atleast one protrusion on the treatment element to deform the tissue.

Different types of energy that may be applied in alternative embodimentsmay include, but are not limited to, ultrasound, microwave, heat,radiofrequency, electrical, light and laser energy. In some embodiments,applying the energy involves delivering radiofrequency energy to one ormore electrodes of the treatment element to locally heat the at leastone tissue, where delivering radiofrequency energy while deforming theat least one tissue causes the tissue to change shape.

In some embodiments, the at least one tissue may include nasal valvetissue. In some embodiments, the at least one tissue may include nasalmucosa at or near a junction of a pyriform aperture and a lower lateralcartilage. In some embodiments, the at least one tissue may includeupper lateral cartilage.

In one embodiment, removing energy may involve using cryogenic therapyprovided by the treatment element. In some embodiments, the energy isapplied to or removed from the at least one tissue while the at leastone tissue is deformed. In some embodiments, the energy applied by thetreatment element may be generated from a power source within thetreatment device.

Optionally, the method may further involve injecting a substance intothe at least one tissue prior to applying the energy, where the appliedenergy affects the injected substance to help modify the property of thetissue. In other embodiments, the method may involve applying asubstance to the at least one tissue or to an outer surface of the nosebefore applying the energy. Substances may provide any of a number ofsuitable benefits, such as reducing pain, increasing conductivity oftissue, promoting tightening of tissue, or the like.

In some embodiments, the property of the tissue is modified withoutreshaping the at least one tissue. In some embodiments, modifying theproperty comprises stiffening the tissue, with or without reshaping it.The tissue (or tissues) can be any suitable tissue, such as but notlimited to epithelium, cartilage, mucosa, sub-mucosa, muscle, ligament,tendon and skin.

Some embodiments may further involve cooling the at least one tissueand/or other tissues in or on the nose, before, during, or afterapplying the energy. In some embodiments, the method may also involvemeasuring at least one parameter at or near the at least one tissue tobe treated and adjusting a level of energy application or removal, basedon the measured parameter. For example, in some embodiments, theparameter may be temperature and/or impedance.

In another aspect, a method of treating a nasal valve of a nose, withoutusing a surgical incision or an implant, to decrease airflow resistanceor perceived airflow resistance in a nasal airway, may involve:contacting a treatment element of a treatment device with an outersurface of the nose; applying energy to at least one of a subdermallayer or a dermal layer of tissue in the nose, using the treatmentelement, wherein the tissue is located at least partially above thenasal valve; and cooling at least one of an epidermal layer or asuperficial dermal layer of the nose, using the treatment device. Insome embodiments, the applied energy comprises thermal energy, andapplying the energy causes at least some of the tissue to tighten. Insome embodiments, the method may also involve applying a substance tothe outer surface of the nose before applying the energy to enhance atleast one of the application of the energy or the cooling epidermallayer or the superficial dermal layer.

In another aspect, a device for treating a patient's nasal airway bymodifying at least one property of at least one tissue of or near anasal valve of the airway, without using a surgical incision or animplant, to decrease airflow resistance or perceived airflow resistancein a nasal airway, may include: an energy delivery member sized to beinserted into a nose and configured to deliver energy to tissues withinthe nose to modify the at least one property of the at least one tissue;a shaft extending from the energy delivery member; and a handle attachedto the shaft at an opposite end from the energy delivery member, whereinthe handle includes a housing to hold a power source for providingenergy to the energy delivery member.

In some embodiments, the energy delivery member may have a contactsurface with convex shape configured to at least temporarily create aconcavity in nasal tissue. In some embodiments, the energy deliverymember may have a contact surface with flat shape. In some embodiments,the energy delivery member may include multiple protruding electrodesconfigured to at least temporarily deform nasal tissue. In someembodiments, the protruding electrodes may include two rows ofelectrodes, where the energy delivery member comprises a bipolar radiofrequency delivery member, and where radio frequency energy travels fromone row of electrodes to the other row of electrodes.

In some embodiments, the housing of the handle is configured to hold atleast one battery. Optionally, some embodiments may also include atleast one sensor configured to sense at least one of temperature orimpedance in nasal tissue. In some embodiments, the sensor may beattached to the device on or near the energy delivery member. Someembodiments may further include a tissue cooling member attached to thedevice at or near the energy delivery member.

These and other aspects and embodiments will be described in furtherdetail below, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF DRAWINGS

Certain preferred embodiments and modifications thereof will becomeapparent to those skilled in the art from the detailed description belowhaving reference to the figures that follow.

FIG. 1 depicts an illustration of bone and cartilage structures of ahuman nose.

FIG. 2A illustrates a cross-sectional view, illustrating tissues andstructures of a human nose.

FIG. 2B shows a detailed cross-sectional view, illustrating a detailedsection of the structures of FIG. 2A.

FIG. 2C illustrates a view of the nostrils, illustrating tissues andstructures of a human nose.

FIG. 3 depicts a schematic illustration of a nasal valve re-shapingtreatment device.

FIG. 4A is a perspective illustration of an embodiment of a treatmentelement shape.

FIG. 4B depicts a perspective illustration of another embodiment of atreatment element shape.

FIG. 4C shows a perspective illustration of another embodiment of atreatment element shape.

FIG. 4D depicts a cross-sectional view of a treatment device, comprisinga plurality of microneedles puncturing tissue in order to applytreatment at a desired tissue depth.

FIG. 5A illustrates one embodiment of a clamp-type nasal valve treatmentdevice.

FIG. 5B illustrates another embodiment of a clamp-type nasal valvetreatment device.

FIG. 6 depicts a partially-transparent perspective view, showing a stentimplanted in a nose.

FIG. 7 depicts a perspective view, illustrating an energy deliveryballoon being inserted into a nose.

FIGS. 8A-8J depict embodiments of various electrode arrangements forapplying energy to the nasal valve area.

FIGS. 9A and 9B illustrate embodiments of devices for applying energy tothe nasal valve area using a monopolar electrode.

FIGS. 10A and 10B illustrate an embodiment of a device for applyingenergy to the nasal valve area using a monopolar electrode and anexternal mold.

FIGS. 11A and 11B illustrate embodiments of devices for applying energyto the nasal valve area using electrode(s) and a counter-tractionelement.

FIGS. 12A and 12B illustrate embodiments of devices for applying energyto the nasal valve area configured to be inserted into both nostrilssimultaneously.

FIGS. 13A-13E illustrate embodiments of devices for applying energy tothe nasal valve area configured to be inserted into both nostrilssimultaneously, having a mold or counter-traction element for engagingthe nose externally.

FIGS. 14A and 14B illustrate embodiments of devices for applying energyto the nasal valve area configured to be inserted into both nostrilssimultaneously, having separate external molds.

FIGS. 15A-15C illustrate embodiments of devices for applying energy tothe nasal valve area configured to be inserted into both nostrilssimultaneously, having separate counter-traction elements.

FIG. 16 shows an embodiment of a system comprising a device for applyingenergy to the nasal valve area with an external electrode and a separateinternal mold.

FIGS. 17A and 17B illustrate an embodiment of a device for applyingenergy to the nasal valve area comprising an external electrode and aninternal mold.

FIG. 18 shows an embodiment of a device for applying energy to the nasalvalve area comprising an array of non-penetrating electrodes.

FIGS. 19A and 19B illustrate an embodiment of a device for applyingenergy to the nasal valve area configured for use in only one nostril.

FIGS. 20A and 20B illustrate an embodiment of a device for applyingenergy to the nasal valve area configured for use in either nostril.

FIGS. 21A and 21B illustrate an embodiment of a device for applyingenergy to the nasal valve area having a symmetrical shape.

FIGS. 22A-22G illustrate an embodiment of a device for applying energyto the nasal valve area using a monopolar electrode.

FIGS. 23A-23G illustrate an embodiment of a device for applying energyto the nasal valve area using an array of needle electrodes.

FIG. 24A depicts a cross-section of tissue at the nasal valve.

FIG. 24B depicts heat effects of RF treatment of tissue at the nasalvalve.

FIGS. 25A and 25B illustrate embodiments of devices for applying energyto the nasal valve area incorporating cooling systems.

FIG. 26 shows an embodiment of a device for applying energy to the nasalvalve area incorporating a heat pipe.

FIG. 27 depicts an embodiment of a device for applying energy to thenasal valve area incorporating heat pipes.

FIGS. 28A-28E depict embodiments of differential cooling mechanisms.

FIG. 29 shows an embodiment of a system comprising a device for applyingenergy to the nasal valve area with electrode needles and a separatecooling mechanism.

FIGS. 30A-30D shows an embodiment of a method for applying energy to thenasal valve area using a device for applying energy to the nasal valvearea.

FIGS. 31A and 31B are perspective and side, cross-sectional views,respectively, of a device for applying energy to the nasal valve area,including an internal power source, according to one embodiment.

FIGS. 32A and 32B are a cross-sectional side view of facial skin and afront view of a face of a patient, respectively, illustrating use ofvarious embodiments of sensors that may be part of a system for applyingenergy to the nasal valve area, according to one embodiment.

FIGS. 33A and 33B are a bottom view of a distal end of a treatmentdevice and a cross-sectional view of a nasal passage, respectively,illustrating wings of the treatment device that may be used to helpguide the distal end to a desired location in the nasal passage.

FIGS. 34A-34C are top views of various alternative embodiments of distalends of treatment devices having different shapes for addressingdifferently shaped tissues.

FIG. 35 is a top view of a treatment device and a cross-sectional viewof a portion of a nose, in which the treatment device includes anexpandable member, according to one embodiment.

FIG. 36 is a diagrammatic representation of an internal nasal valve,illustrating areas for treatment, according to various embodiments.

DETAILED DESCRIPTION

The following disclosure provides embodiments of systems and methods forimproving breathing by decreasing airflow resistance or perceivedairflow resistance at or near a site of an internal or external nasalvalve. Such embodiments may include methods and devices for reshaping,remodeling, strengthening, or changing the properties of the tissues ofthe nose, including, but not limited to the skin, muscle, mucosa,submucosa, and cartilage in the area of the nasal valves.

While, in some instances, nasal dysfunction can lead to poor airflow,nasal breathing can also be improved in people with normal breathingand/or normal nasal anatomy by decreasing nasal airflow resistance inthe nasal valve and associated nasal anatomy. Remodeling or changing thestructure of the nasal valve can improve nasal airflow in people withinadequate nasal airflow resulting from causes other than nasal valvedysfunction, such as deviated septum, enlarged turbinates, mucosalswelling, and/or mucous production. The methods and devices describedabove are generally invasive methods or unsightly devices that a personwith normal breathing and/or anatomy may not necessarily be inclined touse or undergo. Thus, there remains an unmet need in the art fornon-invasive and minimally invasive methods and devices to decreasenasal airflow resistance or perceived nasal airflow resistance and/or toimprove nasal airflow or perceived nasal airflow and the resultingsymptoms or sequella of poor nasal airflow including but not limited tosnoring, sleep disordered breathing, perceived nasal congestion and poorquality of life through the change of structures within the nose thatform the passageways for airflow. Methods and devices described hereinmay be used to treat nasal airways without the need for more invasiveprocedures (e.g., ablation, surgery).

Nasal breathing can be improved in people with normal breathing and/ornormal nasal anatomy by decreasing nasal airflow resistance or perceivednasal airflow resistance in the nasal valve and associated nasalanatomy. Restructuring the shape, conformation, angle, strength, andcross sectional area of the nasal valve may improve nasal airflow.Changing the nasal valve can be performed alone or together with otherprocedures (e.g., surgical procedures), such as those described above.Such methods and devices can lead to improved nasal airflow, increasedvolume of nasal airflow in patients with normal or reduced nasalairflow.

The internal nasal valve area is the narrowest portion of the nasalpassage and thus functions as the primary regulator of airflow andresistance. The cross-sectional area of the internal nasal valve area isnormally about 55-83 mm.sup.2. As described by the Poiseuille law,airflow through the nose is proportional to the fourth power of theradius of the narrowest portion of the nasal passageway. Thus, changesas small as 1 mm in the size of the nasal valve have an exponentialeffect on airflow and resistance through the nasal cavity and the entirerespiratory system.

FIGS. 1 and 2A-C illustrate anatomical elements of a human nose. Thelower lateral cartilage (LLC) includes an external component referred toas the lateral crus and an internal component referred to as the medialcrus. The medial crus and septal nasal cartilage create a nasal septumthat separates the left and right nostrils. Upper lateral cartilage liesbetween the lower lateral cartilages and the nasal bone. The left ULC isseparated from the right ULC by the septal cartilage extending down thebridge of the nose. The opposing edges of the LLC and ULC may moverelative to one another. Disposed between the opposing edges is anaccessory nasal cartilage. The septal nasal cartilage and the ULC forman angle (.THETA.) called the nasal valve angle.

FIG. 2B illustrates a detailed cross-section of a segment of nose tissuein the area of the intersection of the ULC and the LLC. As shown in FIG.2B, the detailed view of FIG. 2A, both inner and outer surfaces of thenasal cartilage are covered with soft tissue including mucosa,sub-mucosa and skin.

FIG. 2C illustrates a view of the nose as seen from the nostrils. FIG.2C depicts the nasal valve 1 shown between the septum 2 and the upperlateral cartilage 3. FIG. 2C also depicts the position of the turbinate4.

The internal nasal valve area of the nasal airway passage can bevisualized prior to and/or during any treatment by any suitable method,including but not limited to direct visualization, endoscopicvisualization, visualization by the use of a speculum,transillumination, ultrasound, MRI, x-ray or any other method. In someembodiments, treatments of the nasal valve area as described herein maybe performed in conjunction with or following another procedure (e.g., asurgical procedure such as surgically repairing a deviated septum). Insuch embodiments, the nasal valve area may be visualized and accessedduring surgery. In some embodiments, it may be desirable to visualizethe internal nasal valve with minimum disturbance, so as to avoidincorrect assessments due to altering the shape of the nasal valveduring visualization. In some embodiments, visualization elements may beincorporated into or combined with treatment devices configured fortreating internal and/or external nasal valves.

Airflow through the nasal passage can be measured prior to and/or duringany treatment by any suitable method, including, but not limited to, anasal cannula connected to a pressure measurement system,rhinomanometry, and rhino-hygrometer. Nasal airflow and resistance canalso be evaluated by subjective evaluation before and after amanipulation to increase the cross-sectional area of the nasal passage,such as the Cottle maneuver. In some embodiments, it may be desirable tomeasure nasal airflow and/or resistance prior to, during and/or after aprocedure.

The internal nasal valve area of the nasal airway passage can beaccessed through the nares. In some embodiments, one or more devices maybe used to pull the tip of the nose caudally and increase the diameterof the nares in order to further facilitate access to the internal nasalvalve for treatment. Such devices may include speculum type devices andretractors. In other embodiments, access to the internal nasal valve mayalso be achieved endoscopically via the nares, or via the mouth andthroat. In some embodiments, visualization devices may be incorporatedor combined with treatment devices for treating internal and/or externalnasal valves. These and any other access and/or visualization devicesmay be used with any of the methods and devices below.

During inhalation, airflow through the nostrils creates an inwardpressure at the junction between the upper and lower cartilages. Thispressure may be expressed as a function of nasal resistance which may beestimated as 10 centimeters of water per one liter per second incongested patients (see “The Four Components of the Nasal Valve” byCole, published in the American Journal of Rhinology, pages 107-110,2003). In response to these low pressures relative to the environmentoutside the nose, a normal, weakened and/or structurally inadequatenasal valve may move inwardly with the junction between the upper andlower cartilages acting as a hinge point for the inward deflection.Furthermore, a small increase in area through which air flows cangreatly decrease the pressure differential in these structures resultingin less inward movement of the internal nasal valve structures.Increasing the cross sectional area of the nasal valve area thus has thebeneficial effects of decreasing nasal airflow resistance and decreasingthe amount and likelihood of inward movement of the nasal valvestructures during inspiration.

Some embodiments below provide apparatus and methods for increasing thearea of the opening at the nasal valve and/or treating nasal valveinsufficiency by modifying the structure and/or structural properties oftissues at or adjacent to the internal and/or external nasal valve.Other embodiments below provide apparatus and methods for treating nasalvalve insufficiency and/or increasing the area of the opening at nasalvalve by re-shaping structures within and/or adjacent to an internaland/or external nasal valve to achieve a more optimum shape and minimizeor remove airflow obstructions. Still other embodiments combine the twoapproaches of re-shaping and modifying tissue and structures of andadjacent to the internal and/or external nasal valves. Still otherembodiments provide apparatus and methods for increasing the area of theopening at the nasal valve and treating nasal obstruction resulting fromcauses other than nasal valve restriction or insufficiency by improvingthe structure or function of the nasal valve tissue to increase airflow.Still other embodiments below provide apparatus and methods fordecreasing airflow resistance in a structurally normal nasal valveand/or increasing the area of the opening at nasal valve by re-shapingstructures within and/or adjacent to an internal and/or external nasalvalve to achieve a more optimum shape and minimize or remove airflowobstructions. For example, patients having a normal nasal valve anatomymay still benefit from the devices and treatments described herein, asimprovement in the nasal valve structure and/or increasing the area ofthe opening at the nasal valve may improve breathing problems caused byother conditions. Still other embodiments provide for structural changesin the nasal cavity and airway that improve the relative positions ofthe structures of the nasal cavity to improve nasal breathing.

In some embodiments, airflow restrictions to the internal nasal valvemay be the result of a smaller-than-optimal internal nasal valve angle,shown as .theta. in FIG. 2. An internal nasal valve angle (i.e. theangle formed between the caudal border of the ULC and the nasal septum)of less than the normally optimal range of between about 10 degrees andabout 15 degrees can result in airflow restrictions. Thus, in someembodiments, treatments may be designed to re-shape structures at oradjacent to the internal nasal valve in order to increase the internalnasal valve angle sufficiently that after such treatments, the nasalvalve angle falls within the optimal range of about 10-15 degrees. Insome embodiments, the internal valve angle may also be increased to begreater than 15 degrees.

In some embodiments, airflow restrictions to the internal nasal valvemay be the result of a smaller-than-optimal area of the internal nasalvalve. An internal nasal valve with a less than optimal area can resultin airflow restrictions. Thus, in some embodiments, treatments may bedesigned to re-shape structures at or adjacent to the internal nasalvalve in order to increase the internal nasal valve angle sufficientlythat after such treatments, the area of the nasal valve falls within anoptimal range. In some embodiments, increasing the area of the openingat the nasal valve without increasing the angle of the nasal valve mayimprove airflow. In some embodiments, increasing the angle of the nasalvalve without increasing the area of the opening at the nasal valve mayimprove airflow. In some embodiments, both the opening at the area ofthe nasal valve and the angle of the nasal valve may be increased toimprove airflow.

In some embodiments, nasal airflow can be increased in the presence ofnormal nasal valve anatomy and/or normal or enlarged nasal valve angleor area.

With reference to FIG. 2A, in some embodiments, the internal valve angle.theta. or area may be increased by mechanically pressing laterallyoutwards against the internal lateral nasal wall. In some embodiments,this outward pressing may be performed by an inflatable balloon (such asthose discussed below with reference to FIGS. 4A-4B) which may bepositioned between the upper portion of the nasal septum 20 and theouter lateral wall 22 and then inflated, pressing against the lateralnasal wall until the nasal valve angle reaches a desired size.Similarly, other mechanical devices such as spreaders or retractors(such as those discussed below with reference to FIGS. 5A & 5B) or moldsmay be used. In alternative embodiments, short-term removable implantsmay be used to re-shape the nasal valve. Some examples of short-termimplants may include stents, molds or plugs. In further alternativeembodiments, external re-shaping elements, such as adhesive strips orface masks may be used to modify the shape of a nasal valve. In someembodiments, energy application or other treatments as described belowmay be applied to substantially fix the re-shaped tissue in a desiredconformational shape before, during or after applying a mechanicalre-shaping force (e.g., with the balloon, mechanical devices, molds,short-term implants, or external re-shaping elements described above orany of the mechanical devices described below).

In another embodiment, a re-shaping device may be used to expand thediameter of the nasal passage at the site of the internal or externalnasal valve. The expansion device can be a balloon, user controlledmechanical device, self expanding mechanical device, fixed shape deviceor any combination thereof. The expansion can increase the diameter overthe normal range in order for the diameter to remain expanded afterremoval of the device and healing of the tissue.

In some embodiments, a re-shaping device may be used to conformationallychange the structure of the internal or external nasal valve anatomy toallow greater airflow without necessarily expanding the diameter of thenasal passage.

In some embodiments, a re-shaping or remodeling device can be used toconformationally change the structure of areas of the internal nasalvalve other than the nasal valve that causes the cross sectional orthree dimensional structure of the nasal airway to assume a shape lessrestrictive to airflow without widening the nasal valve angle.

In some embodiments, the tissue of the internal and/or external nasalvalve and/or surrounding tissues may be strengthened or otherwisemodified to resist a conformational change in response to the negativepressure of inspiration. In some embodiments, this strengthening may beperformed by applying treatments selected to change mechanical orstructural properties of the treated tissue. In some embodiments, suchtreatments may include the application of energy to selected regions ofnasal valve and/or surrounding tissues.

In some embodiments, energy may be applied in the form of heat,radiofrequency (RF), laser, light, ultrasound (e.g. high intensityfocused ultrasound), microwave energy, electromechanical, mechanicalforce, cooling, alternating or direct electrical current (DC current),chemical, electrochemical, or others. In alternative embodiments, thenasal valve and/or surrounding tissues may be strengthened through theapplication of cryogenic therapy, or through the injection orapplication of bulking agents, glues, polymers, collagen and/or otherallogenic or autogenic tissues, or growth agents.

Any one or more of the above energy-application mechanisms may also beused to re-shape, remodel, or change mechanical or physiologicproperties of structures of a nasal valve or surrounding tissues. Forexample, in some embodiments, energy may be applied to a targeted regionof tissue adjacent a nasal valve such that the tissue modificationresults in a tightening, shrinking or enlarging of such targeted tissuesresulting in a change of shape. In some such embodiments, re-shaping ofa nasal valve section may be achieved by applying energy withoutnecessarily applying a mechanical re-shaping force. For example energycan be used to selectively shrink tissue in specific locations of thenasal airway that will lead to a controlled conformational change.

In alternative embodiments, strengthening and/or conformation change(i.e., re-shaping) of nasal valve tissue to reduce negative pressureduring inspiration may include modification of tissue growth and/or thehealing and fibrogenic process. For example, in some embodiments energymay be applied to a targeted tissue in the region of the internal nasalvalve in such a way that the healing process causes a change to theshape of the nasal valve and/or a change in the structural properties ofthe tissue. In some embodiments, such targeted energy application andsubsequent healing may be further controlled through the use oftemporary implants or re-shaping devices (e.g. internal stents or molds,or external adhesive strips).

In some embodiments, energy may be delivered into the cartilage tissueto cause a conformational change and/or a change in the physicalproperties of the cartilage. Energy delivery may be accomplished bytransferring the energy through the tissue covering the cartilage suchas the epithelium, mucosa, sub-mucosa, muscle, ligaments, tendon and/orskin. In some embodiments, energy may also be delivered to the cartilageusing needles, probes or microneedles that pass through the epithelium,mucosa, submucosa, muscle, ligaments, tendon and/or skin (as illustratedfor example in FIG. 4D).

In some embodiments, energy may be delivered into the submucosal tissueto cause a conformational change and/or a change in the physicalproperties of the submucosal tissue. Energy delivery may be accomplishedby transferring the energy through the tissue covering the submucosasuch as the epithelium, mucosa, muscle, ligaments, cartilage, tendonand/or skin. In some embodiments, energy may also be delivered to thesubmucosa using needles, probes, microneedles, micro blades, or othernon-round needles that pass through the epithelium, mucosa, muscle,ligaments, tendon and/or skin.

FIG. 3 illustrates an embodiment of a nasal valve treatment device 30.The device 30 comprises a treatment element 32 which may be configuredto be placed inside the nasal cavity, nasal passage, and/or nasal airwayto deliver the desired treatment. In some embodiments, the device 30 mayfurther comprise a handle section 34 which may be sized and configuredfor easy handheld operation by a clinician. In some embodiments, adisplay 36 may be provided for displaying information to a clinicianduring treatment.

In some embodiments, the information provided on the display 36 mayinclude treatment delivery information (e.g. quantitative informationdescribing the energy being delivered to the treatment element) and/orfeedback information from sensors within the device and/or within thetreatment element. In some embodiments, the display may provideinformation on physician selected parameters of treatment, includingtime, power level, temperature, electric impedance, electric current,depth of treatment and/or other selectable parameters.

In some embodiments, the handle section 34 may also comprise inputcontrols 38, such as buttons, knobs, dials, touchpad, joystick, etc. Insome embodiments, controls may be incorporated into the display, such asby the use of a touch screen. In further embodiments, controls may belocated on an auxiliary device which may be configured to communicatewith the treatment device 30 via analog or digital signals sent over acable 40 or wirelessly, such as via bluetooth, WiFi (or other 802.11standard wireless protocol), infrared or any other wired or wirelesscommunication method.

In some embodiments the treatment system may comprise an electroniccontrol system 42 configured to control the timing, location, intensityand/or other properties and characteristics of energy or other treatmentapplied to targeted regions of a nasal passageway. In some embodiments,a control system 42 may be integrally incorporated into the handlesection 34. Alternatively, the control system 42 may be located in anexternal device which may be configured to communicate with electronicswithin the handle section 34. A control system may include a closed-loopcontrol system having any number of sensors, such as thermocouples,electric resistance or impedance sensors, ultrasound transducers, or anyother sensors configured to detect treatment variables or other controlparameters.

The treatment system may also comprise a power supply 44. In someembodiments, a power supply may be integrally incorporated within thehandle section 34. In alternative embodiments, a power supply 44 may beexternal to the handle section 34. An external power supply 44 may beconfigured to deliver power to the handle section 34 and/or thetreatment element 32 by a cable or other suitable connection. In someembodiments, a power supply 44 may include a battery or other electricalenergy storage or energy generation device. In other embodiments, apower supply may be configured to draw electrical power from a standardwall outlet. In some embodiments, a power supply 44 may also include asystem configured for driving a specific energy delivery technology inthe treatment element 32. For example, the power supply 44 may beconfigured to deliver a radio frequency alternating current signal to anRF energy delivery element. Alternatively, the power supply may beconfigured to deliver a signal suitable for delivering ultrasound ormicrowave energy via suitable transducers. In further alternativeembodiments, the power supply 44 may be configured to deliver ahigh-temperature or low-temperature fluid (e.g. air, water, steam,saline, or other gas or liquid) to the treatment element 32 by way of afluid conduit.

In some embodiments, the treatment element 32 may have a substantiallyrigid or minimally elastic shape sized and shaped such that itsubstantially conforms to an ideal shape and size of a patient's nasalpassageway, including the internal and external nasal valves. In someembodiments, the treatment element 32 may have a curved shape, eitherconcave or convex with respect to the interior of the lateral wall ofthe nasal passage. In some embodiments, the shape of a fixed-shapetreatment element may be substantially in a shape to be imparted to thecartilage or other structures of the internal or external nasal valvearea.

In some embodiments, as shown for example in FIG. 3, the treatmentelement 32 may comprise a substantially cylindrical central portion witha semi-spherical or semi-ellipsoid or another shaped end-cap section atproximal and/or distal ends of the treatment element 32. In alternativeembodiments, the treatment element may comprise a substantiallyellipsoid shape as shown, for example in FIGS. 4A-4D. In someembodiments, an ellipsoid balloon as shown in FIG. 4A may have anasymmetrical shape. In alternative embodiments, the treatment element 32may have an asymmetrical “egg-shape” with a large-diameter proximal endand a smaller-diameter distal end. In some embodiments, the element 32can be shaped so as to impart a shape to the tissue treated that isconducive to optimal nasal airflow. Any suitable solid or expandablemedical balloon material and construction available to the skilledartisan may be used.

FIG. 4B illustrates an embodiment of a treatment element configured todeliver energy to an interior of a nasal valve. In some embodiments, thetreatment element of FIG. 4B also includes an expandable balloon.

FIG. 4C illustrates an embodiment of a bifurcated treatment element 70having a pair of semi-ellipsoid elements 72, 74 sized and configured tobe inserted into the nose with one element 72, 74 on either side of theseptum. The elements may each have a medial surface 75 a & 75 b whichmay be substantially flat, curved or otherwise shaped and configured tolie adjacent to (and possibly in contact with) the nasal septum. In someembodiments, the elements 72, 74 may include expandable balloons withindependent inflation lumens 76, 78. In alternative embodiments, theelements 72, 74 have substantially fixed non-expandable shapes. In stillfurther embodiments, the elements 72, 74 may include substantiallyself-expandable sections. In some embodiments, the bifurcated treatmentelement halves 72, 74 may also carry energy delivery structures asdescribed elsewhere herein. In some embodiments, the shape of theelements 72, 74 may be modified by the operator to impart an optimalconfiguration to the treated tissue. The shape modification of elements72, 74 can be accomplished pre-procedure or during the procedure and canbe either fixed after modification or capable of continuousmodification.

In some embodiments, a nasal valve treatment system may also comprise are-shaping device configured to mechanically alter a shape of softtissue and/or cartilage in a region of a nasal valve in order to imparta desired shape and mechanical properties to the tissue of the walls ofthe nasal airway. In some embodiments the re-shaping device may beconfigured to re-shape the internal and/or external nasal valve into ashape that improves the patency of one or both nasal valve sections atrest and during inspiration and/or expiration. In some embodiments, thereshaping device may comprise balloons, stents, mechanical devices,molds, external nasal strips, spreader forceps or any other suitablestructure. In some embodiments, a re-shaping device may be integrallyformed with the treatment element 32. In alternative embodiments, are-shaping device may be provided as a separate device which may be usedindependently of the treatment element 32. As described in more detailbelow, such re-shaping may be performed before, during or aftertreatment of the nose tissue with energy, injectable compositions orcryo-therapy.

With reference to FIGS. 4A-4C, some embodiments of treatment elements 32may comprise one or more inflatable or expandable sections configured toexpand from a collapsed configuration for insertion into the nasalpassageway, to an expanded configuration in which some portion of thetreatment element 32 contacts and engages an internal surface of a nasalpassageway. In some embodiments, an expandable treatment element maycomprise an inflation lumen configured to facilitate injection of aninflation medium into an expandable portion of the treatment element. Inalternative embodiments, an expandable treatment element may compriseone or more segments comprising a shape-memory alloy material which maybe configured to expand to a desired size and shape in response to achange of temperature past a transition temperature. In someembodiments, such a temperature change may be brought about byactivating an energy-delivery (or removal) element in the treatmentelement 32.

In some embodiments, the treatment element 32 may expand with variouslocations on the element expanding to different configurations or notexpanding at all to achieve a desired shape of the treatment element. Insome embodiments, such expandable treatment elements or sections may beelastic, inelastic, or pre-shaped. In some embodiments, expandabletreatment elements or sections there of may be made from shape-memorymetals such as nickel-cobalt or nickel-titanium, shape memory polymers,biodegradable polymers or other metals or polymers. Expandable balloonelements may be made of any elastic or inelastic expandable balloonmaterial.

In alternative embodiments, the treatment element 32 can act to changethe properties of the internal soft tissue of the nasal airway inconjunction with an external treatment device of fixed or variable shapeto provide additional force to change the shape of the internal and/orexternal nasal valve. In some embodiments, an external mold element canbe combined with an internal element.

FIGS. 5A and 5B illustrate re-shaping treatment devices 80 and 90,respectively. The treatment devices 80 and 90 are structured as clampdevices configured to engage a targeted section of the nasal valve witheither a clamping force or a spreading force. In some embodiments, thetreatment devices of FIGS. 5A and 5B may include energy deliveryelements (of any type described herein) which may be powered by a fluidlumen or cable 86.

The treatment device of FIG. 5A includes an outer clamp member 82 and aninner clamp member 84 joined at a hinge point 85. In some embodiments,the outer clamp member 82 may include an outwardly-bent section 86 sizedand configured to extend around the bulk of a patient's nose when theinner clamp member may be positioned inside the patient's nose. Theinner and outer tissue-engaging tips at the distal ends of the inner andouter clamp members may be configured to impart a desired shape to theinternal and/or external nasal valve. In some embodiments, thetissue-engaging tips may be removable to allow for sterilization and/orto allow for tips of a wide range of shapes and sizes to be used with asingle clamp handle.

The treatment device of FIG. 5B includes an outer clamp member 92 and aninner clamp member 94 joined at a hinge point 95. The inner and outertissue-engaging tips at the distal ends of the inner and outer clampmembers may be configured to impart a desired shape to the internaland/or external nasal valve. In the illustrated embodiment, the outerclamp member 92 includes a concave inner surface, and the inner clampmember includes a mating convex inner surface. The shape and dimensionsof the mating surfaces may be designed to impart a desired shape to thestructures of a patient's nose. In some embodiments, the shape of themating surfaces may be modified by the operator to impart an optimalconfiguration to the treated tissue. The shape modification of themating surfaces can be accomplished pre-procedure or during theprocedure and can be either fixed after modification or capable ofcontinuous modification.

In some embodiments, the tissue-engaging tips may be removable to allowfor sterilization and/or to allow for tips of a wide range of shapes andsizes to be used with a single clamp handle.

In alternative embodiments, the devices of FIGS. 5A and 5B may be usedas spreader devices by placing both clamp tips in one nasal valve andseparating the handles, thereby separating the distal tips. Inalternative embodiments, the handles may be configured to expand inresponse to a squeezing force. The shapes of the distal tips may bedesigned to impart a desired shape when used as a spreading device.

The re-shaping elements of FIGS. 3-5B are generally configured to beused once and removed from a patient's nose once a treatment isdelivered. In some embodiments, treatments may further involve placinglonger term treatment elements, such as stents, molds, external strips,etc. for a period of time after treatment. An example of such a stentplaced within a patient's nose after treatment is shown in FIG. 6. Insome embodiments, the stent may be configured to be removed after atherapeutically effective period of time following the treatment. Insome embodiments, such a therapeutically effective period of time may beon the order of days, weeks or more.

In some embodiments, the treatment element 32 may be configured todeliver heat energy to the nasal valve. In such embodiments, thetreatment element may comprise any suitable heating element available tothe skilled artisan. For example, the treatment element 32 may compriseelectrical resistance heating elements. In alternative embodiments, theheating element may comprise conduits for delivering high-temperaturefluids (e.g. hot water or steam) onto the nasal tissue. In someembodiments, a high-temperature fluid heating element may comprise flowchannels which place high-temperature fluids into conductive contactwith nasal tissues (e.g. through a membrane wall) without injecting suchfluids into the patients nose. In further embodiments, any othersuitable heating element may be provided. In further embodiments, thetreatment element 32 may comprise elements for delivering energy inother forms such as light, laser, RF, microwave, cryogenic cooling, DCcurrent and/or ultrasound in addition to or in place of heatingelements.

U.S. Pat. No. 6,551,310 describes embodiments of endoscopic treatmentdevices configured to ablate tissue at a controlled depth from within abody lumen by applying radio frequency spectrum energy, non-ionizingultraviolet radiation, warm fluid or microwave radiation. U.S. Pat. No.6,451,013 and related applications referenced therein describe devicesfor ablating tissue at a targeted depth from within a body lumen.Embodiments of laser-treatment elements are described for example inU.S. Pat. No. 4,887,605, among others. U.S. Pat. No. 6,589,235 teachesmethods and device for cartilage reshaping by radiofrequency heating.U.S. Pat. No. 7,416,550 also teaches methods and devices for controllingand monitoring shape change in tissues, such as cartilage. The devicesdescribed in these and other patents and publications available to theskilled artisan may be adapted for use in treating portions of a nasalvalve or adjacent tissue as described herein. U.S. Pat. Nos. 7,416,550,6,589,235, 6,551,310, 6,451,013 and 4,887,605 are hereby incorporated byreference in their entireties.

In alternative embodiments, similar effects can be achieved through theuse of energy removal devices, such as cryogenic therapies configured totransfer heat energy out of selected tissues, thereby lowering thetemperature of targeted tissues until a desired level of tissuemodification is achieved. Examples of suitable cryogenic therapydelivery elements are shown and described for example in U.S. Pat. Nos.6,383,181 and 5,846,235, the entirety of each of which is herebyincorporated by reference.

In some embodiments, the treatment element 32 may be configured todeliver energy (e.g. heat, RF, ultrasound, microwave) or cryo-therapyuniformly over an entire outer surface of the treatment element 32,thereby treating all nasal tissues in contact with the treatment element32. Alternatively, the treatment element 32 may be configured to deliverenergy at only selective locations on the outer surface of the treatmentelement 32 in order to treat selected regions of nasal tissues. In suchembodiments, the treatment element 32 may be configured so that energybeing delivered to selected regions of the treatment element can beindividually controlled. In some embodiments, portions of the treatmentelement 32 are inert and do not deliver energy to the tissue. In furtheralternative embodiments, the treatment element 32 may be configured withenergy-delivery (or removal) elements distributed over an entire outersurface of the treatment element 32. The control system 42 may beconfigured to engage such distributed elements individually or inselected groups so as to treat only targeted areas of the nasalpassageway.

In some embodiments, the treatment element 32 may be a balloon withenergy delivery elements positioned at locations where energy transferis sufficient or optimal to effect change in breathing. Such a balloonmay be configured to deliver energy while the balloon is in an inflatedstate, thereby providing a dual effect of repositioning tissue anddelivering energy to effect a change the nasal valve. In otherembodiments, a balloon may also deliver heat by circulating a fluid ofelevated temperature though the balloon during treatment. The ballooncan also delivery cryotherapy (e.g. by circulating a low-temperatureliquid such as liquid nitrogen) while it is enlarged to increase thenasal valve diameter or otherwise alter the shape of a nasal valve. FIG.7 illustrates an example of an energy-delivery balloon being insertedinto a patient's nose for treatment. Several embodiments may be employedfor delivering energy treatment over a desired target area. For example,in some embodiments, a laser treatment system may treat a large surfacearea by scanning a desired treatment pattern over an area to be treated.In the case of microwave or ultrasound, suitably configured transducersmay be positioned adjacent to a target area and desired transducerelements may be activated under suitable depth focus and power controlsto treat a desired tissue depth and region. In some embodiments,ultrasound and/or microwave treatment devices may also make use oflenses or other beam shaping of focusing devices or controls. In someembodiments, one or more electrical resistance heating elements may bepositioned adjacent to a target region, and activated at a desired powerlevel for a therapeutically effective duration. In some embodiments,such heating elements may be operated in a cyclical fashion torepeatedly heat and cool a target tissue. In other embodiments, RFelectrodes may be positioned adjacent to and in contact with a targetedtissue region. The RF electrodes may then be activated at some frequencyand power level therapeutically effective duration. In some embodiments,the depth of treatment may be controlled by controlling a spacingbetween electrodes. In alternative embodiments, RF electrodes mayinclude needles which may puncture a nasal valve tissue to a desireddepth (as shown for example in FIG. 4D and in other embodiments below).

In some embodiments, the treatment element 32 and control system 42 maybe configured to deliver treatment energy or cryotherapy to a selectedtissue depth in order to target treatment at specific tissues. Forexample, in some embodiments, treatments may be targeted at tighteningsections of the epithelium of the inner surface of the nasal valve. Inother embodiments, treatments may be targeted at strengthening softtissues underlying the epithelium. In further embodiments, treatmentsmay be targeted at strengthening cartilage in the area of the upperlateral cartilage. In still further embodiments, treatments may betargeted at stimulating or modifying the tissue of muscles of the noseor face in order to dilate the nasal valve.

In some embodiments, the treatment element 32 and control system 42 maybe configured to deliver treatment energy to create specific localizedtissue damage or ablation, stimulating the body's healing response tocreate desired conformational or structural changes in the nasal valvetissue.

In some embodiments, the treatment element 32 and control system 42 maybe configured to create specific localized tissue damage or ablationwithout the application of energy. For example the treatment element 32may be configured to chemically cauterize tissue around a nasal valve bydelivering a cauterizing agent (e.g., silver nitrate, trichloroaceticacid, cantharidin, etc.) to the tissue. The treatment element 32 maycomprise apertures configured to permit the cauterizing agent passthrough to the nose. In some embodiment, the treatment element 32 mayaerosolize the cauterizing agent. Other delivery methods are alsocontemplated. The treatment element 32 may comprise a lumen throughwhich the cauterizing agent passes. The lumen may be fluidly connectedto a reservoir or container holding the cauterizing agent. The devicemay comprise an input control (e.g., a button or switch) configured tocontrol the delivery of the cauterizing agent. In some embodiments, thetreatment element 32 comprises an applicator that can be coated in acauterizing agent (e.g., dipped in a reservoir of cauterizing agent,swabbed with cauterizing agent, etc.) and the coated treatment elementapplicator may be applied to tissue to be treated. In some embodiments,the treatment element may be configured to apply cauterizing agent tothe patient over a prolonged period of time (e.g., 30 seconds, 1 minute,2 minutes, etc.). In some embodiment, the treatment element 32 comprisesshields configured to protect tissue surrounding the tissue to betreated from coming into contact with the cauterizing agent. In someembodiments, a separate element is used to shield tissue surrounding thetissue to be treated from coming into contact with the cauterizingagent. While such treatments may be performed without the application ofenergy, in some embodiments, they are performed in conjunction withenergy treatments.

In some embodiments, a treatment element may be configured to treat apatient's nasal valve by applying treatment (energy, cryotherapy, orother treatments) from a position outside the patient's nose. Forexample, in some embodiments, the devices of FIGS. 5A and 5B may beconfigured to apply energy from an element positioned outside apatient's nose, such as on the skin. In another embodiment, a device maybe placed on the external surface of the nose that would pull skin toeffect a change in the nasal airway. Treatment may then be applied tothe internal or external nasal tissue to achieve a desired nasal valvefunction.

In some embodiments, the device is configured to position tissue to bere-shaped. In some embodiments, the device comprises features andmechanisms to pull, push or position the nasal tissue into a mold forre-shaping. For example, suction, counter traction, or compressionbetween two parts of the device may be used.

In some embodiments, the treatment device comprises one, two, three,four, or more molds configured to re-shape tissue. The mold orre-shaping element may be fixed in size or may vary in size. The moldmay also be fixed in shape or may vary in shape. For example, the sizeor shape of the element may be varied or adjusted to better conform to anasal valve of a patient. Adjustability may be accomplished using avariety of means, including, for example, mechanically moving the moldby way of joints, arms, guidewires, balloons, screws, stents, andscissoring arms, among other means. The mold may be adjusted manually orautomatically. The mold is configured to impart a shape to the tissuesof the nasal valve area to improve airflow or perceived airflow. Themold is configured to act near the apex of the nasal valve angle, thepoint at which the upper lateral cartilage meets the cartilage of thenasal septum. It may be desirable to treat in an area near, but not at,the nasal valve so as to avoid post procedure scarring and/or adhesions.This may be accomplished by focusing treatment on the lateral part ofthe nasal valve angle.

In some embodiments, the mold or re-shaping element comprises a separateor integrated energy delivery or treatment element (e.g., an electrodesuch as those described below with respect to FIGS. 8A-8J). Thetreatment element may be fixed or adjustable in size. For example, thetreatment element may be adjusted to better conform to the nasal valveof a patient. In the case of a separate re-shaping element and treatmentelement, a distance between the two elements may either be fixed oradjustable. Adjustability may be accomplished using a variety of means,including, for example, mechanically moving the mold by way of joints,arms, guidewires, balloons, screws, stents, and scissoring arms, amongother means.

In some embodiments, the mold or another part of the device isconfigured to deliver cooling (discussed in more detail below). In someembodiments, the mold or re-shaping element comprises a balloonconfigured to reshape and/or deform tissue. A balloon may also beconfigured to deliver energy such as heat using hot liquid or gas.

Examples of Various Electrode Arrangements

Described below are embodiments of various treatment devices and, moreparticularly, electrode arrangements that may be used for applyingenergy to the nasal valve area. These electrodes may, for example,deliver RF energy to preferentially shape the tissue to provide improvednasal breathing. In some embodiments, one or more electrodes may be usedalone or in combination with a tissue shaping device or mold. In otherembodiments, one or more electrodes may be integrally formed with atissue shaping device or mold, so that the electrodes themselves createthe shape for the tissue. In some embodiments, the energy deliverydevices may utilize alternating current. In some embodiments, the energydelivery devices may utilize direct current. In certain suchembodiments, the energy delivery device may comprise a configurationutilizing a grounding pad.

In some embodiments, the term “electrode” refers to any conductive orsemi-conductive element that may be used to treat the tissue. Thisincludes, but is not limited to metallic plates, needles, and variousintermediate shapes such as dimpled plates, rods, domed plates, etc.Electrodes may also be configured to provide tissue deformation inaddition to energy delivery. Unless specified otherwise, electrodesdescribed can be monopolar (e.g., used in conjunction with a groundingpad) or bipolar (e.g., alternate polarities within the electrode body,used in conjunction with other tissue-applied electrodes).

In some embodiments, “mold”, “tissue shaper”, “re-shaping element” andthe like refer to any electrode or non-electrode surface or structureused to shape, configure or deflect tissue during treatment.

In some embodiments, “counter-traction” refers to applying a forceopposite the electrode's primary force on the tissue to increasestability, adjustability, or for creating a specific shape.

As shown in FIG. 8A, in some embodiments, bipolar electrodes may be usedto deliver energy, with one electrode 202 placed internally in the nasalvalve, for example against the upper lateral cartilage, and oneelectrode 204 placed externally on the outside of the nose. Thisembodiment may advantageously provide direct current flow through thetissue with no physical trauma from needles (as shown in someembodiments below). As shown in FIG. 8B, in some embodiments, bipolarelectrodes may be used to deliver energy, with both electrodes 210, 212placed internally. An insulating spacer 214 may be placed between them.This embodiment may be simple and may advantageously minimize currentflow through the skin layer. In some embodiments, bipolar electrodes220, 222 may be both placed externally and may be connected to a passivemolding element 224 placed inside the nasal valve adjacent to tissue tobe treated, as shown in FIG. 8C. This embodiment may advantageouslyminimize the potential for mucosal damage. In some embodiments,electrodes placed internally may be shaped to function as a mold or maycomprise an additional structure that may function as a mold.

In some embodiments, a monopolar electrode may be used to deliverenergy. As shown in FIG. 8D, the electrode 230 may be placed internallyand may be connected to an external, remote grounding pad 232. Thegrounding pad 232 may, for example, be placed on the abdomen of apatient or in other desired locations. This embodiment mayadvantageously be simple to manufacture and may minimize current flowthrough the skin. In some embodiments, a monopolar electrode may beplaced externally and may be connected to a molding element placedinside the nasal valve as well as a remote grounding pad. Thisembodiment may also advantageously be simple to manufacture, mayminimize mucosal current flow, and may also be simple to position. Insome embodiments, electrodes placed internally may be shaped to functionas a mold or may comprise an additional structure that may function as amold.

In some embodiments, monopolar transmucosal needles may be used todeliver energy. The needle electrodes 240 may be placed internally, asshown in FIG. 8E penetrating through the mucosa to the cartilage, and aremote grounding pad 242 or element may be placed externally. In someembodiments, monopolar transmucosal needles may be used in conjunctionwith one or more molding elements which may be disposed on or around theneedles. In some embodiments, monopolar transdermal needles may be usedto deliver energy. In other embodiments (not shown), the needles may beplaced external to the nose, and penetrate through to tissue to betreated. Needle configurations may advantageously target the cartilagetissue to be treated specifically. The monopolar transdermal needles maybe used in conjunction with an internal molding device (not shown).

In some embodiments, bipolar transmucosal needles may be used to deliverenergy to tissue to be treated. The needles may be placed internally,with an insulating spacer between them and may penetrate through themucosa to the cartilage to be treated. In some embodiments, the bipolartransmucosal needles may be used in combination with one or moreinternal molding elements. The one or more molding elements may beplaced on or near the needles. In some embodiments, bipolar transdermalneedles may be used to deliver energy. In other embodiments, thetransdermal needles may be placed externally and penetrate through totissue to be treated. Needle configurations may advantageously targetthe cartilage tissue to be treated specifically. The transdermal bipolarneedles may be utilized in conjunction with an internal molding element.

As shown in FIG. 8F, in some embodiments, an array of electrodescomprising one, two, or many pairs of bipolar needles 252 are located ona treatment element configured to be placed into contact with thecartilage. An insulator 254 may be disposed between the bipolar needles252. An insulator may also be utilized on part of the needle's length toallow energy to be delivered only to certain tissue structures, such ascartilage. The electrodes may be placed either internally ortransmucosally or they may be placed externally or transdermally. In theembodiment illustrated in FIG. 8F, the insulator 254 may also functionas a mold or molding element. In other embodiments (not shown), thearray of electrodes is used in conjunction with a separate tissuere-shaping element.

FIG. 8G illustrates another embodiment of a treatment element comprisesone, two or many pairs of bipolar electrodes 260. As opposed to FIG. 8F,where the pairs of electrodes are arranged side-by-side, the embodimentof FIG. 8G arranges the pairs of electrodes along the length of thetreatment element. The electrodes of FIG. 8G are also non-penetrating,in contrast to the needles of FIG. 8F. The electrodes 260 may be placedagainst either the skin, externally, or the mucosa, internally as ameans of delivering energy to target tissue such as cartilage.

In some embodiments of treatment devices comprising an array or multiplepairs of electrodes, each pair of electrodes (bipolar) or each electrode(monopolar) may have a separate, controlled electrical channel to allowfor different regions of the treatment element to be activatedseparately. For example, the needles or needle pairs of FIG. 8F may beindividually controlled to produce an optimal treatment effect. Foranother example, the separate electrodes of FIGS. 8B and 8C may beindividually controlled to produce an optimal treatment effect. Otherexamples are also contemplated. The channels may also comprise separateor integrated feedback. This may advantageously allow for more accuratetemperature control and more precise targeting of tissue. Separatecontrol may also allow energy to be focused and/or intensified on adesired region of the treatment element in cases where the anatomy ofthe nasal tissue/structures does not allow the entire electrode regionof the treatment element to engage the tissue. In such embodiments, thenasal tissue that is in contact with the treatment element may receivesufficient energy to treat the tissue.

Combinations of the described electrode configurations may also beutilized to deliver energy to tissue to be treated (e.g., by beingreshaped). For example, transmucosal needles 264 may be placedinternally, penetrating through to the tissue to be treated, and anelectrode 266 may be placed externally, as shown in FIG. 8H. Thisembodiment may advantageously target the cartilage tissue specificallyand be biased for mucosal preservation. For another example, transdermalneedles 268 may be placed externally and an electrode 270 may be placedinternally, as shown in FIG. 8I. This embodiment may advantageouslytarget the cartilage tissue specifically and be biased towards skinpreservation. For another example bipolar needle electrodes 272, 274 canbe placed both transdermally or externally and transmucosally orinternally, as shown in FIG. 8J. This embodiment may advantageouslytarget the cartilage tissue specifically. Some embodiments of treatmentelements may include inert areas which do not delivery energy to thetissue. Other combinations of electrode configuration are also possible.

Examples of Treatment Devices Including Electrodes

Embodiments of treatment devices incorporating treatment elements suchas the electrodes described above are illustrated in FIGS. 9A-21B. Theinstrument designs described in these embodiments may be used in adevice such as the device 30, described above, and in the system of FIG.3. In some embodiments, the devices provide tissue re-shaping or moldingin addition to energy delivery. Applying energy to the nasal valve mayrequire properly positioning the electrode(s) at the nasal valve,deflecting or deforming the tissue into a more functional shape, anddelivering or applying energy consistently prior to device removal.Embodiments described herein may advantageously provide adjustability,visualization of effect, ease of use, ease of manufacturability andcomponent cost. Molding and reshaping of the tissues of the nasal valvemay allow for non-surgical nasal breathing improvement without the useof implants.

FIG. 9A depicts a device 300 comprising a single inter-nasal monopolarelectrode 301 located at the end of a shaft 302. The shaft is attachedto a handle 303. The electrode configuration may be similar to thatdescribed with respect to FIG. 8D. FIG. 9B depicts another device 304comprising a single inter-nasal, monopolar electrode 305. The electrode305 is located at the distal end of a shaft 306, which is attached to ahandle 307. The handle comprises a power button 308 that may be used toactivate and deactivate the electrode. As stated above, the device 304may either comprise a generator or be connected to a remote generator.The electrode 305 may be provided on an enlarged, distal end of theshaft 306, and in the embodiment illustrated has a convex shapeconfigured to press against and create a concavity in the nasal valvecartilage.

FIG. 10A depicts a side view of a device 310 comprising a singleinter-nasal electrode 312 located at the end of a shaft 314. The shaftis attached to a handle 316. An external mold 318 is attached to thehandle 316 and can be moved relative to the electrode shaft 314. Theexternal mold 318 has a curved shape with an inner concave surface thatmay be moved in order to press against an external surface of apatient's nose to compress tissue between the external mold 318 and theelectrode 312. FIG. 10B provides a front view of the device 310.

FIG. 11A depicts a device 320 comprising a single inter-nasal electrode322 attached to the end of a shaft 324. The shaft 324 is attached to ahandle 326. An internal shaft 328 comprising a tissue-contacting surfaceis attached to the handle 326. The internal shaft 328 can be movedrelative to the electrode shaft 324 and may provide counter-tractionand/or positioning. For example, when the electrode 322 is placedagainst a patient's upper lateral cartilage, the counter-tractionelement 328 may be pressed against the patient's nasal septum.

FIG. 11B depicts a device 450 similar to device 320 of FIG. 11Acomprising an inter-nasal electrode 451 located at a distal end of ashaft 452 connected to a handle 454. The device 450 further comprises acounter-traction element 456 connected to a handle 458. Like the device320 depicted in FIG. 11A, the connection 460 between the two handles454, 458 is such that squeezing the two handles 454, 458 together causesthe electrode 451 and the counter-traction element 456 to move away fromeach other, spreading the tissue they are contacting.

FIG. 12A depicts a device 330 comprising a single inter-nasal electrode332 located at the end of a shaft 334. The shaft 334 is attached to ahandle 336. The device 330 comprises another single inter-nasalelectrode 338 attached to the end of a shaft 340. The shaft 340 isattached to a handle 342. The device comprises a connection 344 betweenthe two handles 336, 342 that allows simultaneous deformation andtreatment of both nostrils.

FIG. 12B depicts a device 470 similar to device 330 of FIG. 12Acomprising a first inter-nasal electrode 472 located at a distal end ofa shaft 474 connected to a handle 476. The device 470 comprises a secondinter-nasal electrode 478 located at a distal end of a second shaft 480connected to a second handle 482. The connection 484 between the twohandles 476, 482 is such that squeezing the handles 476, 482 togethercauses the electrodes 472, 478 to move away from one another, spreadingany tissue they may be in contact with. The device 470 comprises aratcheting mechanism 475 between the two handles 476, 482 that allowsthe relative positions of the electrodes 472, 478 to be locked duringtreatment.

FIG. 13A depicts a side view of a device 350 also used for treating twonostrils comprising an inter-nasal electrode 352 attached to the end ofa shaft 354. The shaft 354 is attached to a handle 356. As seen in thefront view provided in FIG. 13B, the device 350 comprises a secondinter-nasal electrode 358. The second inter-nasal electrode 358 isattached to the end of a shaft which is attached to a handle. Aconnection between the two handles allows simultaneous deformation andtreatment of the nostrils. An external mold 366 is attached to thehandles. The mold 366 may be moved relative to the electrode shafts 354,360 and may provide counter-traction (e.g., against the bridge of thenose) and positioning.

FIGS. 13C-E depicts a device 490 similar to the device 350 shown in FIG.13A and FIG. 13B. FIGS. 13C and 13D depict side and top views of adevice 490 comprising a handle 492. The handle 492 bifurcates into afirst shaft 494 with a first inter-nasal electrode 496 located at adistal end of the shaft 494 and a second shaft 498 with a secondinter-nasal electrode 500 located at a distal end of the shaft 498. Thedevice 490 comprises a mold 502 configured to provide counter-tractionor compression of the bridge of the nose. The mold 502 comprises ahandle 504. The connection 506 between the handles 492, 504 is such thatsqueezing the two handles 492, 504 causes the electrodes 496, 600 andthe mold 502 to be compressed together. FIG. 13E depicts the device 490being used on a patient. The arrows indicate the directions in which thehandles 492, 504 are configured to be squeezed.

FIG. 14A depicts a front view of a device 370 comprising an inter-nasalelectrode 372 attached to the end of a shaft 374 (shown in top view ofFIG. 14B). The shaft 374 is attached to a handle 376. The device 370comprises a second inter-nasal electrode 378 attached to the end of asecond shaft 380. The second shaft 380 is attached to a second handle382. A connection 384 between the two handles 376, 382 may allowsimultaneous deformation and treatment of the nostrils. External molds386, 388 are attached to the handles and can be moved relative to eachelectrode shaft 374, 380. The molds 386, 388 may providecounter-traction, compression of tissue, positioning, and externaltissue deformation.

FIG. 15A depicts a front view of device 390 comprising a firstinter-nasal electrode 392 and a second inter-nasal electrode 398. Asshown in the side view of FIG. 15B, the device 390 comprises a firstinter-nasal electrode 392 attached to the end of a shaft 394. The shaftis attached to a handle 396. A second inter-nasal electrode 398 isattached to the end of a second shaft 400, as shown in the top view ofFIG. 15C. The second shaft 400 is attached to a second handle 402. Aconnection 404 between the two handles 396, 402 may allow simultaneousdeformation and treatment of the nostrils. Additional internal shafts406, 408 comprise tissue-contacting surfaces and are attached to thehandles 396,402. The internal shafts 406, 408 may be moved relative toeach electrode shaft 394, 400 (shown in FIG. 15B) and may providecounter-traction and positioning.

FIG. 16 depicts a system 410 comprising a first device having anextra-nasal electrode 412 along a concave surface configured topositioned against an external surface of a patient's nose, theelectrode 412 being attached to the end of a shaft 414. The shaft 414 isattached to a handle 416. A separate device 417 comprising an internaltissue mold 418 is attached to a shaft 420. The internal tissue mold isconfigured to be positioned inside the patient's nasal valve. The shaft420 is attached to a handle 422. Each handle 422, 416 may be manipulatedindividually and may apply energy and deformation to create a desiredtissue effect.

FIG. 17A depicts a side view of a device 430 comprising an extra-nasalelectrode 431 attached to the end of a shaft 432. The shaft 432 isattached to a handle 434. The device 430 also comprises an internaltissue mold 436 attached to a shaft 438 which is attached to a handle440. The handles 434, 440 are attached together and may be movedrelative to each other to simultaneously deliver energy and deformtissue. FIG. 17B depicts a front view of the device 430.

FIG. 18 depicts a device 390 comprising pairs of bipolar electrodes 392located at the distal end of a shaft 394. The electrodes may be similarto the electrodes described with respect to the electrode configurationof FIG. 8G in that they are non-penetrating. The shaft 394 is connectedto a handle 398 which comprises a button 395 configured to activate anddeactivate the electrodes. As stated above, the device 380 may eithercomprise a generator or be connected to a remote generator.

FIG. 19A depicts the treatment element 502 of a treatment device (e.g.,device 30). The treatment element 502 of the device comprises amonopolar electrode 504. A cross-section of the treatment element 502 isshown in FIG. 19B. It comprises an asymmetrical shape and has a convexsurface where the electrode is positioned configured to conform to onlyone of a patient's nostrils (for example, a patient's right nostril).More specifically, the convex surface is configured such that wheninserted into the particular nostril, the convex surface would belocated adjacent the upper lateral cartilage of the nasal valve of thatnostril. The treatment element 502 further comprises a light 507configured to illuminate the treatment area. For example an LED or avisible laser may be used. The visible laser may experience lessdiffusion in the tissue. Furthermore, the light 507 can be situated suchthat light can be transmitted through the nasal tissue (including theskin) and can be visualized externally by the user. The user can thenuse the light to properly position the device in the desired location.Because the electrode 504 is not centered on the treatment element 502of the device, a separate device having a mirror-image configuration maybe required to treat the other nostril.

FIG. 20A depicts the treatment element 512 of a treatment device (e.g.,device 30). The treatment element 512 of the device comprises twomonopolar electrodes 514, 516 provided side-by-side on a convex surfaceof the treatment element. The cross section of the treatment element512, shown in FIG. 20B, is configured to conform to the shape eithernostril, depending on which side of the device (and accordingly, whichof electrode 514 or 516) is placed in contact with the patient's nasalvalve. Comprising two monopolar electrodes 514, 516 may allow the sametreatment element 512 to be used for treatment in both nostrils, andeach electrode may be activated separately depending on which side needsto be utilized. The treatment element 512 also comprises two lights 518,520 (e.g., LEDs, lasers) configured to illuminate the treatment area forboth nostrils. One or both of the lights 518, 520 can also be situatedsuch that light can be transmitted through the nasal tissue (includingthe skin) and can be visualized externally by the user. The user canthen use the light to properly position the device in the desiredlocation.

FIG. 21A depicts a treatment element 522 of a treatment device (e.g.,device 30). The tip 522 of the device comprises a monopolar electrode524. The tip 522 comprises a symmetrical cross-section as shown in FIG.21B. The tip 522 comprises a light 526 (e.g., LED) configured toilluminate the treatment area. The light 526 can also be situated suchthat light can be transmitted through the nasal tissue (including theskin) and can be visualized externally by the user. The symmetrical tipallows the user to treat either left or right nostril. The user can thenuse the light to properly position the device in the desired location.

FIGS. 22A-G depict a treatment device 530 similar to the embodiments ofFIGS. 8D, 9A, and 9B. FIGS. 22A and 22F provide perspective views of thedevice 530. The device 530 comprises a treatment element 532 at itsdistal tip 534. The treatment element 532 comprises an electrode 535.The body of the treatment element 532, itself, may comprise aninsulating material. The treatment element 532 may be provided on anenlarged distal tip 534 of an elongate shaft 536, and as in theembodiment illustrated, may have a convex shape configured to pressagainst and create a concavity in the nasal valve cartilage (e.g., inthe upper lateral cartilage near the nasal valve). The distal tip 534 islocated at the distal end of shaft 536. The shaft is attached at itsproximal end to a handle 538. The handle 538 comprises an input controlsuch as a power button 540 on its front side that may be used toactivate and deactivate the electrode. The power button 540 may bepositioned in a recess of the handle to allow for finger stability whenactivating and deactivating the electrode. In other embodiments, theinput control is in the form of a switch or dial. Other configurationsare also possible as described above.

The device 530 comprises a flexible wire or cable 542 electricallyconnected to an adaptor 544. The adaptor 544 can be used to connect thedevice 530 to a remote generator (not shown). The adaptor 544 may allowtransmission of treatment energy between a remote generator and thedevice 530. The adaptor may also allow transmission of any sensorsignals between the device 530 and a generator or control unit. Thedevice 530 may either comprise an integrated generator or be connectedto a remote generator. The treatment device 530 may be provided in asystem or kit also including the remote generator. The system or kit(with or without the remote generator) may also include a groundingdevice and/or a cooling device as described above and further below. Insome embodiments, the kit includes a positioning element (e.g., a“cottle” device) configured to help a user locate the optimal treatmentarea.

FIGS. 22B and 22C depict front and back views of the device. As shown inFIGS. 22B and 22C, the handle 538 of the device generally as a roundedelongate shape. Other shapes are also possible. For example the device530 may have a square shaped cross section. In some embodiments, acircumference (or width or cross-sectional area) of the handle 538 mayincrease distally along the length of the handle 538.

FIGS. 22D and 22E depict side views of the device. As shown in FIGS. 22Dand 22E, the handle 538 of the device 530 may comprise an indentation orrecess around the middle of the handle 538. This may allow for enhancedgrip and control when a user is holding the device. The indentation orrecess may be near the input control or power button 540 to allow a userto easily activate and deactivate the device while holding it in acomfortable position.

In some embodiments, the shaft has a width or diameter of about 0.125inches to about 0.25 inches. In some embodiments, the shaft is about 1.5inches to about 4 inches long. In some embodiments, the shaft comprisesa polymer such as polycarbonate or PEEK. In other embodiments, the shaftcomprises stainless steel or other metals. The metals may be coated withan external and/or internal insulating coating (e.g., polyester,polyolefin, etc.). The handle may comprise the same material as theshaft, in some embodiments. In some embodiments, the shaft is rigid.This may allow a user of the device increased control over thedeformation of nasal tissue. In some embodiments, the shaft comprisessome amount of flexibility. This flexibility may allow a user adjust anangle of the distal tip by bending the distal end of the shaft.

FIG. 22G depicts a larger view of the distal tip 534 of the device 530.As shown best in FIG. 22G, the treatment element 532 comprises agenerally elongate shape. The front of the treatment element 532comprises a shallow, curved surface, providing a convex shape configuredto deform the nasal tissue and create a concavity therein. In someembodiments, the front of the treatment element comprises a concaveshape. The shape of the front surface of the treatment element may beselected to conform to the nasal tissue. The back of the treatmentelement 532 also comprises a shallow curved surface. As best seen inFIGS. 22D and 22E, the back surface varies in width along the length ofthe back surface of the treatment element 532. The back surface widens,moving distally along the tip until it is nearly in line with theproximal end of the electrode plate 532. The back surface then narrowstowards the distal tip of the treatment element 532. This shape maymaximize visualization of the area to be treated, while, at the sametime, providing sufficient rigidity for treatment. Other shapes are alsopossible. For example, the treatment element may comprise a generallyspherical or cylindrical shape. In some embodiments, the treatmentelement comprises an angular shape (e.g., triangular, conical) which mayallow for close conformation to the tissue structures. The treatmentelement 532 comprises a monopolar electrode plate 532. The monopolarelectrode plate 532 can be in the shape of a rectangle having a curvedor convex tissue-facing surface. Other shapes are also possible (e.g.,square, circular, ovular, etc.). The electrode 532 may protrude slightlyfrom the treatment element 535. This may allow the electrode to itselfprovide a convex shape configured to create a concavity in tissue to betreated.

In some embodiments, the treatment element has a width or diameter ofabout 0.25 inches to about 0.45 inches. In some embodiments, thetreatment element is about 0.4 inches to about 0.5 inches long. Thetreatment element can, in some embodiments, comprise a ceramic material(e.g., zirconium, alumina, silicon glass). Such ceramics mayadvantageously possess high dielectric strength and high temperatureresistance. In some embodiments, the treatment element comprisespolyimides or polyamides which may advantageously possess gooddielectric strength and elasticity and be easy to manufacture. In someembodiments, the treatment element comprises thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the treatment elementcomprises thermoset polymers, which may advantageously provide gooddielectric strength and good elasticity. In some embodiments, thetreatment element comprises glass or ceramic infused polymers. Suchpolymers may advantageously provide good strength, good elasticity, andgood dielectric strength.

In some embodiments, the electrode has a width of about 0.15 inches toabout 0.25 inches. In some embodiments, the electrode is about 0.2inches to about 0.5 inches long. In some embodiments, the treatmentelement comprises steel (e.g., stainless, carbon, alloy). Steel mayadvantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein comprise materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein compriseanodized aluminum. Anodized aluminum may advantageously be highly stiffand low in cost. In some embodiments, the electrodes or energy deliveryelements described herein comprise titanium which may advantageouslypossess a high strength to weight ratio and be highly biocompatible. Insome embodiments, the electrodes or energy delivery elements describedherein comprise nickel titanium alloys. These alloys may advantageouslyprovide high elasticity and be biocompatible. Other similar materialsare also possible.

As shown in the embodiment of FIG. 22G, the treatment element 532further comprises a pin-shaped structure comprising a thermocouple 533within an insulating bushing extending through a middle portion of theplate 532. In some embodiments, different heat sensors (e.g.,thermistors) may be used. In some embodiments, the thermocouple 533 isconfigured to measure a temperature of the surface or subsurface oftissue to be treated or tissue near the tissue to be treated. Apin-shape having a sharp point may allow the structure to penetrate thetissue to obtain temperature readings from below the surface. Thethermocouple can also be configured to measure a temperature of thetreatment element 532 itself. The temperature measurements taken by thethermocouple can be routed as feedback signals to a control unit (e.g.,the control unit 42 described with respect to FIG. 3) and the controlunit can use the temperature measurements to adjust the intensity ofenergy being delivered through the electrode. In some embodiments,thermocouples or other sensing devices may be used to measure multipletissue and device parameters. For example, multiple thermocouples orthermistors may be used to measure a temperature at different locationsalong the treatment element. In some embodiments, one of the sensors maybe configured to penetrate deeper into the tissue to take a measurementof a more interior section of tissue. For example, a device may havemultiple sensors configured to measure a temperature at the mucosa, thecartilage, and/or the treatment element itself. As described above, insome embodiments, the sensors described herein are configured to take ameasurement of a different parameter. For example, tissue impedance canbe measured. These measurements can be used to adjust the intensityand/or duration of energy being delivered through the treatment element.This type of feedback may be useful from both an efficacy and a safetyperspective.

As shown in FIG. 22G, in some embodiments the thermocouple is within apin shaped protrusion on the surface of the electrode 532. In otherembodiments, the thermocouple can simply be on the surface of theelectrode. In other embodiments, the thermocouple can protrude from thesurface of the electrode in a rounded fashion. Rounded structures may bepressed into the tissue to obtain subsurface temperature readings. Otherconfigurations and locations for the thermocouple are also possible. Theuse of thermocouples or temperature sensors may be applied not only tothe embodiment of FIG. 22G, but also to any of the other embodimentsdescribed herein.

FIGS. 23A-G depict a treatment device 550 similar to the embodiments ofFIGS. 8F and 18. FIGS. 23A and 23F are perspective views of the device550 and show the device 550 comprising a treatment element 552 at thedistal tip 556 of the device 550. The treatment element 552 may beprovided on an enlarged distal tip 556 of an elongate shaft 558, and asin the embodiment illustrated, may have a convex shape configured topress against and create a concavity in the nasal valve cartilage (e.g.,in upper lateral cartilage of the nasal valve). The distal tip 556 islocated at a distal end of shaft 558. The shaft is attached at itsproximal end to a handle 560. The handle 560 comprises an input control,such as a power button 562, on its front side that may be used toactivate and deactivate the electrode. The power button may bepositioned in a recess of the handle to allow for finger stability whenactivating and deactivating the electrode. In other embodiments, theinput control is in the form of a switch or dial. Other configurationsare also possible as described above. The device 550 may either comprisea generator or be connected to a remote generator. The device 550 maycomprise a flexible wire or cable 564 that connects to an adaptor 566that is configured to be plugged into a remote generator (not shown).The adaptor 566 may allow transmission of treatment energy between aremote generator and the device 550. The adaptor 566 may also allowtransmission of any sensor signals between the device 550 and agenerator or control unit. The treatment device 550 may be provided in asystem or kit also including the remote generator. The system or kit(with or without the remote generator) may also include a groundingdevice and/or a cooling device as described above and further below. Insome embodiments, the kit includes a positioning element (e.g., a“cottle” device) configured to help a user locate the optimal treatmentarea.

In some embodiments, the shaft has a width or diameter or about 0.235inches to about 0.25 inches. In some embodiments, the shaft is about 1.5inches to about 4 inches long. In some embodiments, the shaft and/orhandle comprises a polymer such as polycarbonate or PEEK. In otherembodiments, the shaft comprises stainless steel or other metals. Themetals may be coated with an external and/or internal insulating coating(e.g., polyester, polyolefin, etc.). The handle may comprise the samematerial as the shaft, in some embodiments. In some embodiments, theshaft is rigid. This may allow a user of the device increased controlover the deformation of nasal tissue. In some embodiments, the shaftcomprises some amount of flexibility. This flexibility may allow a useradjust an angle of the distal tip by bending the distal end of theshaft.

FIGS. 23B and 23C depict side views of the device. As shown in FIGS. 23Band 23C, the handle 560 of the device 550 may comprise an indentation orrecess around the middle of the handle 560. This may allow for enhancedgrip and control when a user is holding the device. The indentation orrecess may be near the input control or power button 562 to allow a userto easily activate and deactivate the device while holding it in acomfortable position.

FIGS. 23D and 23E depict front and back views of the device. As shown inFIGS. 23D and 23E, the handle 560 of the device generally comprises arounded elongate shape. Other shapes are also possible. For example thedevice 550 may have a square shaped cross section. In some embodiments,a circumference (or width or cross-sectional area) of the handle 560 mayincrease distally along the length of the handle 560.

FIG. 23G depicts a larger view of the distal tip 556 of the device 550.As shown best in FIG. 23G, the treatment element 552 comprises agenerally elongate shape. The front of the treatment element 552comprises a shallow curved surface, providing a convex shape configuredto deform the nasal tissue and create a concavity therein. In someembodiments, the front of the treatment element comprises a concaveshape. The shape of the front surface of the treatment element may beselected to conform to the nasal tissue. The back surface of thetreatment element 552 comprises a shallow curved surface along most ofits length. As best seen in FIGS. 23B and 23C, the back surface narrowsdistally along the length of the element 552 from approximately thedistal end of the needle electrodes to the distal tip of the treatmentelement 552. This shape may maximize visualization of the area to betreated, while, at the same time, providing sufficient rigidity fortreatment. Other shapes are also possible. For example, the treatmentelement may comprise a generally spherical or cylindrical shape. In someembodiments, the treatment element comprises an angular shape (e.g.,triangular, conical) which may allow for close conformation to thetissue structures. The treatment element 552 comprises a monopolar orbipolar needle array comprising multiple needles 554. In someembodiments, the needles 554 are energized in between select needles todeliver bipolar energy. In other embodiments, the energy is deliveredbetween the needles (554) and a remote grounding pad (not shown). Insome embodiments, the electrode needle pairs are arranged horizontallyacross the treatment element 552. In some embodiments, the electrodeneedle pairs are arranged vertically across the treatment element 552,or along the direction of the shaft 558 and handle 560. Otherconfigurations are also possible. For example, the needle pairs may bearranged diagonally across the treatment element 552. The treatmentelement 552 may be placed either internally, with the needle pairs 554positioned transmucosally or the treatment element 552 may be placedexternally with the needle pairs 554 positioned transdermally. Thedistal tip 556 of the device 550 may also function as a mold or moldingelement. In a monopolar embodiment, the energy may be selectivelydelivered between certain sets of needles, all needles, or evenindividual needles to optimize the treatment effect.

The treatment element 552 of the device 550 further comprises apin-shaped structure comprising a thermocouple 555 within an insulatingbushing extending through a middle portion of the front surface of thetreatment element 552. In some embodiments, different heat sensors(e.g., thermistors) may be used. As described above, in someembodiments, the thermocouple 555 is configured to measure a temperatureof the surface or subsurface of tissue to be treated or tissue near thetissue to be treated. A pin-shape having a sharp point may allow thestructure to penetrate the tissue to obtain temperature readings frombelow the surface. The thermocouple can also be configured to measure atemperature of the treatment element 552 itself. The temperaturemeasurements taken by the thermocouple can be routed as feedback signalsto a control unit (e.g., the control unit 42 described with respect toFIG. 3) and the control unit can use the temperature measurements toadjust the intensity of energy being delivered through the electrode. Insome embodiments, thermocouples or other sensing devices may be used tomeasure multiple tissue and device parameters. For example, multiplethermocouples or thermistors may be used to measure a temperature atdifferent locations along the treatment element. In some embodiments,one of the sensors may be configured to penetrate deeper into the tissueto take a measurement of a more interior section of tissue. For example,a device may have multiple sensors configured to measure a temperatureat the mucosa, the cartilage, and/or the treatment element itself. Asdescribed above, in some embodiments, the sensors described herein areconfigured to take a measurement of a different parameter. For example,tissue impedance can be measured. These measurements can be used toadjust the intensity and/or duration of energy being delivered throughthe treatment element. This type of feedback may be useful from both anefficacy and a safety perspective.

In some embodiments, the treatment element has a width or diameter ofabout 0.25 inches to about 0.45 inches. In some embodiments, thetreatment element is about 0.4 inches to about 0.5 inches long. Thetreatment element can, in some embodiments, comprise a ceramic material(e.g., zirconium, alumina, silicon glass). Such ceramics mayadvantageously possess high dielectric strength and high temperatureresistance. In some embodiments, the treatment element comprisespolyimides or polyamides which may advantageously possess gooddielectric strength and elasticity and be easy to manufacture. In someembodiments, the treatment element comprises thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the treatment elementcomprises thermoset polymers, which may advantageously provide gooddielectric strength and good elasticity. In some embodiments, thetreatment element comprises glass or ceramic infused polymers. Suchpolymers may advantageously provide good strength, good elasticity, andgood dielectric strength.

In some embodiments, the electrodes have a width or diameter of about0.15 inches to about 0.25 inches. In some embodiments, the electrode isabout 0.2 inches to about 0.5 inches long. In some embodiments, thetreatment element comprises steel (e.g., stainless, carbon, alloy).Steel may advantageously provide high strength while being low in costand minimally reactive. In some embodiments, the electrodes or energydelivery elements described herein comprise materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein compriseanodized aluminum. Anodized aluminum may advantageously be highly stiffand low in cost. In some embodiments, the electrodes or energy deliveryelements described herein comprise titanium which may advantageouslypossess a high strength to weight ratio and be highly biocompatible. Insome embodiments, the electrodes or energy delivery elements describedherein comprise nickel titanium alloys. These alloys may advantageouslyprovide high elasticity and be biocompatible. Other similar materialsare also possible.

Energy applied to the tissue to be treated using any combination of theembodiments described in this application may be controlled by a varietyof methods. In some embodiments, temperature or a combination oftemperature and time may be used to control the amount of energy appliedto the tissue. Tissue is particularly sensitive to temperature; soproviding just enough energy to reach the target tissue may provide aspecific tissue effect while minimizing damage resulting from energycausing excessive temperature readings. For example, a maximumtemperature may be used to control the energy. In some embodiments, timeat a specified maximum temperature may be used to control the energy. Insome embodiments, thermocouples, such as those described above, areprovided to monitor the temperature at the electrode and providefeedback to a control unit (e.g., control system 42 described withrespect to FIG. 3). In some embodiments, tissue impedance may be used tocontrol the energy. Impedance of tissue changes as it is affected byenergy delivery. By determining the impedance reached when a tissueeffect has been achieved, a maximum tissue impedance can be used tocontrol energy applied.

In the embodiments described herein, energy may be produced andcontrolled via a generator that is either integrated into the electrodehandpiece or as part of a separate assembly that delivers energy orcontrol signals to the handpiece via a cable or other connection. Insome embodiments, the generator is an RF energy source configured tocommunicate RF energy to the treatment element. For example, thegenerator may comprise a 460 KHz sinusoid wave generator. In someembodiments, the generator is configured to run between about 1 and 100watts. In some embodiments, the generator is configured to run betweenabout 5 and about 75 watts. In some embodiments, the generator isconfigured to run between about 10 and 50 watts.

In some embodiments, the energy delivery element comprises a monopolarelectrode (e.g., electrode 535 of FIG. 22G). Monopolar electrodes areused in conjunction with a grounding pad. The grounding pad may be arectangular, flat, metal pad. Other shapes are also possible. Thegrounding pad may comprise wires configured to electrically connect thegrounding pad to an energy source (e.g., an RF energy source).

In some embodiments, the energy delivery element such as the electrodesdescribed above can be flat. Other shapes are also possible. Forexample, the energy delivery element can be curved or comprise a complexshape. For example, a curved shape may be used to place pressure ordeform the tissue to be treated. The energy delivery element maycomprise needles or microneedles. The needles or microneedles may bepartially or fully insulated. Such needles or microneedles may beconfigured to deliver energy or heat to specific tissues while avoidingtissues that should not receive energy delivery.

In some embodiments, the electrodes or energy delivery elementsdescribed herein comprise steel (e.g., stainless, carbon, alloy). Steelmay advantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein comprise materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein compriseanodized aluminum. Anodized aluminum may advantageously be highly stiffand low in cost. In some embodiments, the electrodes or energy deliveryelements described herein comprise titanium which may advantageouslypossess a high strength to weight ratio and be highly biocompatible. Insome embodiments, the electrodes or energy delivery elements describedherein comprise nickel titanium alloys. These alloys may advantageouslyprovide high elasticity and be biocompatible. Other similar materialsare also possible.

In some embodiments, the treatment elements (e.g., non-electrode portionof treatment element) of the devices described herein, including but notlimited to FIGS. 8A-J, 9A-B, 10A-b, 11A-B, 12A-B, 13A-E, 14A-B, 15A-C,16, 17A-B, 18, 22A-G, 19A-B, 20A-B, 21A-B, 22A-G, 23A-G, 25A-B, 26, 27,28A-E, and 29, comprise an insulating material such as a ceramicmaterial (e.g., zirconium, alumina, silicon glass). In some embodiments,the treatment elements comprise an insulating material interposedbetween multiple electrodes or electrode section. These insulatingsections may provide an inert portion of the treatment element that doesnot delivery energy to the tissue. Such ceramics may advantageouslypossess high dielectric strength and high temperature resistance. Insome embodiments, the insulators described herein comprise polyimides orpolyamides which may advantageously possess good dielectric strength andelasticity and be easy to manufacture. In some embodiments, theinsulators described herein comprise thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the insulatorsdescribed herein comprise thermoset polymers, which may advantageouslyprovide good dielectric strength and good elasticity. In someembodiments, the insulators described herein comprise glass or ceramicinfused polymers. Such polymers may advantageously provide goodstrength, good elasticity, and good dielectric strength.

In some embodiments, the handle and/or shaft of the devices comprise thesame materials as those described with respect to the insulators. Insome embodiments, the handle and/or shaft of the device comprises ametal, such as stainless steel. In other embodiments, the handle and/orshaft of the device comprises a polymer, such as polycarbonate. Othermetals and polymers are also contemplated.

In some embodiments, the device may be used in conjunction with apositioning element that can be used to aid in positioning of thedevice. The positioning element may be integrated into the device itselfor can be separate. The positioning element may be used to determine theoptimal placement of the device to achieve maximal increase in efficacy.In some embodiments, a positioning element is configured to be insertedand manipulated within the nose until the patient reports a desiredimprovement in breathing. The treatment device may then be used to treatwhile the positioning element is holding the nose in the desiredconfiguration. In some embodiments, molds described herein may be usedfor the same purpose.

In some embodiments, a positioning element comprises a shaft comprisingmeasurement marks indicating depth. For example, a physician may insertthis element into the nose to manipulate the tissue to find the depth oftreatment at which the patient reports the best breathing experience.The positioning element may comprise marks around the base of the shaftindicating which point of rotation of the device within the nostrilprovides the best breathing experience. The positioning element may alsocomprise marks indicating angle of insertion. The physician may then usethe measurement marks to guide insertion of the treatment element to thesame spot.

It will be appreciated that any combination of electrode configurations,molds, handles, connection between handles, and the like may be used totreat the nasal valve. Cooling Systems

Embodiments of devices configured to heat specific tissue whilemaintaining lower temperatures in other adjacent tissue are provided.These devices may be incorporated into any of the treatment apparatusesand methods described herein. The nasal valve is an example of a tissuecomplex that includes adjacent tissues that may benefit from beingmaintained at different temperatures. Other examples include the skin,which comprises the epidermis, dermis, and subcutaneous fat, thetonsils, which comprise mucosa, glandular tissue, and vessels. Treatmentof other tissue complexes is also possible. For example, in someembodiments, the internal structures of the nasal valve may be heatedwhile maintaining a lower temperature in the mucosal lining of the noseand/or skin. In other embodiments, the mucosa may be heated, whilemaintaining lower temperatures in the skin. Limiting unwanted heating ofnon-target tissues may allow trauma and pain to be reduced, may reducescarring, may preserve tissue function, and may also decrease healingtime. Combinations of heat transfer and/or heat isolation may allowdirected treatment of specific tissue such as cartilage, while excludinganother tissue, such as mucosa, without surgical dissection.

Generally, when using a device 570 with an electrode 572 (e.g.,monopolar RF electrode) to heat nasal cartilage, the electrode 572 mustbe in contact with the mucosa. FIG. 24A shows a cross-section of tissueat the nasal valve. The cross-section shows that the nasal cartilage 704sits in between a layer of mucosa (internal) 702 and a layer of skin(external) 706. When the electrode 572 is activated, both the mucosa andthe cartilage are heated by the current flowing from the electrode tothe return (e.g., ground pad), as shown in FIG. 24B. The tissue closestto the electrode 572 receives the highest current density, and thus, thehighest heat. A surface cooling mechanism may allow the temperature ofthe electrode surface to be reduced. Such a cooling mechanism maymaintain a lower temperature at the mucosa even though current flow willcontinue to heat the cartilage.

FIG. 25A depicts a device 580 configured to treat the nasal valve usingan electrode while maintaining a reduced temperature at the mucosa. Thedevice comprises a treatment element 582 comprising an electrode 584 atthe distal tip of the device 580. The treatment element 582 is attachedto a distal end of a shaft 586, which is attached to the distal end of ahandle 588. Input and output coolant lines 590, 592 are attached to apump and reservoir 594 and extend into the handle 588, through thedistal end of the treatment element 582 to the electrode 582 and returnback through the shaft 586 and handle 588 to the pump and reservoir 594.The coolant may be remotely cooled in the reservoir and may comprise afluid or gas. The coolant flowing through the electrode 582 may allowthe treatment element 582 to be maintained at a reduced temperaturewhile still allowing current flow to heat the cartilage. Examples ofcoolant include air, saline, water, refrigerants, and the like. Watermay advantageously provide moderate heat capacity and be non reactive.Refrigerants may advantageously be able to transfer significant amountsof heat through phase change. The coolant may flow through internal orexternal cavities of the electrode or wand tip. For example, FIG. 25Bdepicts an embodiment of a device 600 comprising a treatment element 602with an electrode 604 at the distal tip of the device 600. The treatmentelement 602 is attached to the distal end of a shaft 606 which isattached to the distal end of a handle 608. The handle may be attachedto a cable comprises a lumen or channel 611 through which gas or fluidmay flow. The lumen 611 may diverge, near the treatment element 602,into separate external channels flowing over the electrode 604. Thelumen 611 and channels 610 or cavities may be attached to a fan or fluidpump 612. In some embodiments, the fan or fluid pump may remotely coolthe gas or fluid.

FIG. 26 depicts another embodiment of a device 620 configured to treatthe nasal valve using an electrode 624 while maintaining a reducedtemperature at the mucosa and/or skin. The device comprises a treatmentelement 622 comprising an electrode 624 at its distal end. The treatmentelement 622 is connected to the distal end of a shaft 626 which isconnected to the distal end of a handle 628. The device 620 comprises aheat pipe 630 attached to the electrode 624 or treatment element 622.The heat pipe 630 is configured to transfer heat to a remote heat sink632. As shown in FIG. 26, the heat sink 632 may be placed in the handleof the device. In some embodiments, the heat sink may be placedremotely. The heat pipe 630 may comprise a sealed tube (e.g., a coppertube) filled with a material that evaporates at a given temperature.When one end of the heat pipe 630 is heated, the fluid may evaporate andflow to the opposite end where it may condense and subsequently transferheat to the heat sink 632. Using a material such as copper for the heatpipe 630 and/or heat sink 632 may advantageously provide high heat andelectrical conductivity.

FIG. 27 depicts another embodiment of a device 640 configured to treatthe nasal valve using a bipolar electrode pair while maintaining areduced temperature at the skin. The device 640 comprises a firsttreatment element 642 comprising a first electrode 644 of a bipolarelectrode pair at the distal end of a shaft 646. The treatment element642 comprises a thermocouple pin 650 like that described with respect toFIG. 22G. The shaft 646 is connected to the distal end of a handle 648.The handle 648 is connected to another handle 652 comprising a shaft 654with a treatment element 656 at its distal tip. The treatment element656 comprises a second electrode 657 of the bipolar electrode pair. Thefirst and second treatment elements 642, 656 can be placed on eitherside of nasal tissue. For example, the first treatment element 642 maybe in contact with the mucosa and the second treatment element 656 maybe in contact with the skin. Similar to the device depicted in FIG. 26,the device of FIG. 27 comprises a heat pipe within both shafts 654, 646.Thus heat from the tissue is transferred from the treatment elements642, 656 and is transported down the shafts 654, 646 into an integratedor a remote heat sink (not shown). This heat transfer may keep the skinand the mucosa relatively cool while still delivering sufficienttreatment energy to the cartilage. The connection 658 and spring 647between the two handles 648, 652 is configured to bias the two shafts646, 654 and treatment elements 642, 656 towards a collapsed state.Squeezing the handles 648, 652 may separate the two shafts 646, 654 andtreatment elements 642, 656. Thus, the handles 648, 652 can be squeezedto properly position the device 640 at the nasal tissue to be treated.Releasing the handles 648, 652 can cause the treatment element 642 andthe cooling element 656 to contact the tissue. In some embodiments, thedevice 640 may only comprise one heat pipe. In some embodiments, thedevice 640 may comprise a treatment element with a monopolar electrodeon one shaft and a molding element on the other shaft. Multipleconfigurations are contemplated. For example, the device may compriseone heat pipe and a bipolar electrode pair. For another example, thedevice may comprise one heat pipe and a monopolar electrode. For anotherexample, the device may comprise two heat pipes and a monopolarelectrode. Other device configurations are also possible.

The embodiments described with respect to FIGS. 25A-27 employ specificdifferential cooling mechanisms to maintain different and particulartemperatures in adjacent tissues. FIGS. 28A-28E depicts various examplesof more general mechanisms configured to maintain different temperaturesin adjacent tissues. FIGS. 28A-28E depict examples of differentialcooling mechanisms as applied to a cross-section of tissue at the nasalvalve, like that shown in FIG. 24A.

As shown in FIG. 28A, in some embodiments, the differential coolingmechanism comprises two elements: a first element 708 and a secondelement 710. The two elements are on either side of the thickness of thenasal tissue. In one embodiment, the mechanism is configured to maintainnormal temperatures in the cartilage 704 while cooling the mucosa 702and the skin 706. In such an embodiment, the first and second elements708, 710 comprise a cooling apparatus such as those described above(e.g., heatsink, coolant lines, etc.). In some embodiments, the mucosa702 and the skin 706 are heated while normal temperatures are maintainedin the cartilaginous middle layer 704. The cartilage 704 may be somewhatwarmed, in such embodiments, but may be cooler than the mucosa 702 andthe skin 706. In such embodiments, the first and second elements 708,710 comprise a heating apparatus, such as radio frequency electrodes orresistive heating elements. In some embodiments, the mucosa 702 isheated, the skin 706 is cooled, and normal temperatures are maintainedin the cartilage 704. In such embodiments, the first element 708comprises a heating apparatus and the second element 710 comprises acooling apparatus. For example, the device 580, described with respectto FIG. 27, may use such a mechanism. In some embodiments, the skin 706is heated, the mucosa 702 is cooled, and normal temperatures aremaintained in the cartilage 704. In such embodiments, the first element708 comprises a cooling apparatus and the second element 710 comprises aheating apparatus. Again, the device 580, described with respect to FIG.27, is an example of a device that may use such a mechanism.

FIG. 28B shows an example of one of the embodiments described withrespect to FIG. 28A. The first element 730 is on the mucosal surface702. The second element 732 is an energy delivery element and ispositioned on the skin side 706 of the tissue thickness. The firstelement 730 comprises a cooling apparatus and the second element 732comprises an energy delivery element (e.g., an RF electrode). Themucosal layer 702 is cooled while the skin 706 and cartilaginous areas704 are heated. In other embodiments, the first element 730 can bepositioned on the skin 706 and the second element 732 can be positionedon the mucosa 702. In such embodiments, the skin 706 is cooled while themucosa 702 and the cartilage 704 are heated.

As shown in FIG. 28C, in some embodiments, the differential coolingmechanism comprises a first element 720 and a second element 722. Bothelements 720, 722 are on the mucosa 702 side of the tissue thickness. Insome embodiments, the mucosal layer 702 is cooled while highertemperatures are maintained in the middle cartilaginous layer 704. Insuch embodiments, the first element 720 comprises a cooling apparatus,and the second element 722 comprises an energy delivery apparatus (e.g.,a monopolar radiofrequency electrode). In some embodiments, the firstelement 720 is sufficiently efficient to maintain cool temperatures atthe mucosa 702 despite the energy provided by the second element 722. Inother embodiments, the first and second elements 720, 722 are bothpositioned on the skin side 706 of the tissue thickness. In suchembodiments, the skin 706 is cooled while higher temperatures aremaintained in the middle cartilaginous layer.

As shown in FIG. 28D, in some embodiments, the differential coolingmechanism comprises a first surface element 740 and a second surfaceelement 742 on either side of the tissue thickness. A third subsurfaceelement 744 is engaged through the mucosa 702 and into the cartilagearea 704. In some embodiments, the mucosa 702 and the skin 706 arecooled while the middle cartilaginous layer 704 is heated. In suchembodiments, the first and second elements 740, 742 comprise coolingapparatus while the third element 744 comprises a heating element (e.g.,RF monopolar electrode, RF bipolar needles, etc.). In other embodiments,the third subsurface element 744 may be engaged through the skin 706 andinto the cartilage area 704.

As shown in FIG. 28E, in some embodiments, the differential coolingmechanism comprises a first surface element 750 and a second surfaceelement 752 on either side of the tissue thickness. The differentialcooling mechanism further comprises a third surface element 754 and afourth surface element 756 on either side of the tissue thickness. Insome embodiments, the cartilage layer 704 is heated while the mucosa 702and the skin 706 are cooled. In such embodiments, the first and secondelements 750, 752 comprise cooling apparatus and the third and fourthelements 754, 756 comprise energy delivery apparatuses (e.g., bipolarplate electrodes). In some embodiments, the cartilage 704 and mucosal702 layers are heated while the skin 706 is cooled. In such embodiments,the first element 750 comprises a heating apparatus; the second element752 comprises a cooling apparatus; and the third and fourth elements754, 756 comprise energy delivery apparatuses. It will be appreciatedthat different differential temperature effects can be achieved byreconfiguring and adding or subtracting to the described configurationof elements.

Cooling occurring before, during, or after treatment may effect reducedtemperature of the skin and/or mucosa. In some embodiments, attachingpassive fins or other structures to the electrode or wand tip may allowfor heat dissipation to the surrounding air. In some embodiments, thedevice may be configured to spray a cool material such as liquidnitrogen before, during, or after treatment. Using a material such ascopper for the passive fins or other structure may advantageouslyprovide high heat and electrical conductivity. In some embodiments,using metals with a high heat capacity in the device (e.g., in theenergy delivery element, the re-shaping element, or both) mayadvantageously provide the ability to resist temperature change duringenergy delivery. In some embodiments, pre-cooling the electrode (e.g.,by refrigeration, submersion, spraying with a cool substance like liquidnitrogen, etc.) may maintain a reduced temperature at the mucosa. Anycombination of the cooling methods described herein may be used inconjunction with any of the energy delivery methods described herein(e.g., bipolar RF electrodes, arrays needles, plates, etc.). Forexample, FIG. 29 depicts an embodiment of a device 800 comprising atreatment element 802 comprising electrode needles 804 at its distaltip. The device 800 may be used in conjunction with a separate coolingdevice 810 which may comprise channels 815 or cavities to circulate airor fluid. The independent cooling device 810 may, in other embodiments,employ a different cooling mechanism.

In embodiments using laser energy to heat cartilage, it is possible touse a combination of two or more lasers whose beams converge at alocation within the target tissue. This convergence may cause more heatat that junction as compared to locations where only a single beam isacting. The junction may be controlled manually or via computer control.Specific treatment may be provided.

In some embodiments, insulating material may be used to protectnon-target tissue during energy delivery. For example, an electrodeneedle may be preferentially insulated on a portion of the needle thatis in contact with non-target tissue. For another example, flatelectrode blades may be insulated on a portion of the blade that is incontact with non-target tissue. Other configurations for heat isolationare also possible.

Any of the cooling mechanisms or combinations of the cooling mechanismsdescribed herein may be used in conjunction with any of the devices orcombinations of devices described herein, or the like.

Examples of Methods of Treatment

Embodiments of methods for treating nasal airways are now described.Such methods may treat nasal airways by decreasing the airflowresistance or the perceived airflow resistance at the site of aninternal or external nasal valve. Such treatments may also addressrelated conditions, such as snoring.

In one embodiment, a method of decreasing airflow resistance in a nasalvalve comprises the steps of inserting an energy-delivery orcryo-therapy device into a nasal passageway, and applying energy orcryo-therapy to a targeted region or tissue of the nasal passageway. Forexample, in some embodiments, the method may include delivering energyor cryo-therapy to a section of internal nasal valve cartilage in thearea of the upper lateral cartilage, or in the area of intersection ofthe upper and lower lateral cartilage. In alternative embodiments, themethod may deliver energy to the epithelium, or underlying soft tissueadjacent to the upper lateral cartilage and/or the intersection of theULC and the LLC.

In another embodiment, a method comprises heating a section of nasalvalve cartilage to be re-shaped, applying a mechanical re-shaping force,and then removing the heat. In some embodiments, the step of applying amechanical re-shaping force may occur before, during or after the stepof applying heat.

In some embodiments, the method may further include the step ofinserting a re-shaping device into the nasal passageway after applyingan energy or cryo-therapy treatment. In such embodiments, a re-shapingdevice such as an external adhesive nasal strip (such as those describedfor example in U.S. Pat. No. 5,533,499 to Johnson or U.S. Pat. No.7,114,495 to Lockwood, the entirety of each of which is herebyincorporated by reference) may be applied to the exterior of the noseafter the treatment in order to allow for long-term re-shaping of nasalvalve structures as the treated tissues heal over time. In alternativeembodiments, a temporary internal re-shaping device (such as thosetaught in U.S. Pat. No. 7,055,523 to Brown or U.S. Pat. No. 6,978,781 toJordan, the entirety of each of which is hereby incorporated byreference) may be placed in the nasal passageway after treatment inorder to allow for long-term re-shaping of nasal valve structures as thetreated tissues heal over time. In some embodiments, the dilating nasalstrips can be worn externally until healing occurs.

In alternative embodiments, internal and/or external re-shaping devicesmay be used to re-shape a nasal valve section prior to the step ofapplying energy or cryo-therapy treatments to targeted sections of theepithelial, soft tissue, mucosa, submucosa and/or cartilage of the nose.In some embodiments, the energy or cryo-therapy treatment may beconfigured to change the properties of treated tissues such that thetissues will retain the modified shape within a very short time of thetreatment. In alternative embodiments, the treatment may be configuredto re-shape nasal valve structures over time as the tissue heals.

In some embodiments, a portion of the nose, the nasal valve and/or thesoft tissue and cartilage of the nasal valve may be reshaped using are-shaping device and then fixed into place. In some embodiments, suchfixation may be achieved by injecting a substance such as a glue,adhesive, bulking agent or a curable polymer into a region of the nasaltissue adjacent the target area. Alternatively, such a fixationsubstance may be applied to an external or internal surface of the nose.

In some embodiments, an injectable polymer may be injected into a regionof the nose, either below the skin on the exterior of the nose, or underthe epithelium of the interior of the nose. In some embodiments, aninjectable polymer may include a two-part mixture configured topolymerize and solidify through a purely chemical process. One exampleof a suitable injectable two-part polymer material is described in USPatent Application Publication 2010/0144996, the entirety of which ishereby incorporated by reference. In other embodiments, an injectablepolymer may require application of energy in order to cure, polymerizeor solidify. A re-shaping device may be used to modify the shape of thenasal valve before or after or during injection of a polymer. Inembodiments employing an energy-curable polymer, a re-shaping device mayinclude energy-delivery elements configured to deliver energy suitablefor curing the polymer to a desired degree of rigidity.

In another embodiment, the soft tissue of the upper lip under the naresmay be debulked or reshaped to reduce airflow resistance. In someembodiments, such re-shaping of the upper lip soft tissue may beachieved by applying energy and/or cryotherapy from an external and/orinternal treatment element. In some embodiments, the tissue of the upperlip under the nares may be compressed by an internal or external deviceprior to or during application of the energy or cryo-therapy. Forexample, devices such as those shown in FIGS. 5A and 5B may be adaptedfor this purpose by providing tissue-engaging clamp tips shaped for thepurpose.

In another embodiment, the muscles of the nose and/or face arestimulated to dilate the nasal valve area prior to or during applicationof other treatments such as energy/cryo application or fixationtreatments. In such embodiments, the muscles to be treated may includethe nasal dilator muscles (nasalis) the levetator labii, or other facialmuscles affecting the internal and/or external nasal valves. In someembodiments, the targeted muscles may be stimulated by applying anelectric current to contract the muscles, mentally by the patient, ormanually by the clinician.

In some embodiments, the muscles of the nose and/or face may also beselectively deactivated through chemical, ablative, stimulatory, ormechanical means. For example, muscles may be deactivated by temporarilyor permanently paralyzing or otherwise preventing the normal contractionof the muscle tissue. Chemical compounds for deactivating muscle tissuesmay include botulinum toxin (aka “botox”), or others. Ablativemechanisms for deactivating muscle tissue may include RF ablation, laserablation or others. Mechanical means of deactivating muscle tissues mayinclude one or more surgical incisions to sever targeted muscle tissue.

In another embodiment, the tissue of the nasal valve may be reshaped byapplying energy to the internal and external walls of the nasal valveusing a clamp like device as illustrated for example in FIGS. 5A and 5B.One arm of the clamp may provide inward pressure to the external, skinside tissue covering the nasal valve and the other side of the clamp mayprovide outward pressure to the mucosal tissue on the lateral wall ofthe nasal airway above the ULC and LLC or both.

In some embodiments, energy may be applied to the skin of the nose toeffect a shrinkage of the skin, epidermis, dermis, subdermal,subcutaneous, tendon, ligament, muscle, cartilage and/or cartilagetissue. The tissue shrinkage is intended to result in a change of forcesacting on the tissues of the nasal valve to improve airflow through thenasal airway.

In another embodiment, the nasal valve tissue may be damaged orstimulated by energy application, incisions, injections, compression, orother mechanical or chemical actions. Following such damage, a devicemay be used on the tissue to mold or shape the tissue of the valveduring healing. In some embodiments, such a re-shaping device may betemporarily placed or implanted inside or outside the patient's nose tohold a desired shape while the patient's healing process progresses.

In another embodiment, the aesthetic appearance of the nose may beadjusted by varying the device design and/or treatment procedure. Thepredicted post-procedure appearance of the nose may be shown to thepatient through manipulating the nasal tissue to give a post procedureappearance approximation. The patient may then decide if the predictedpost procedure appearance of the face and nose is acceptable or if thephysician needs to change parameters of the device or procedure toproduce an appearance more acceptable to the patient.

In another embodiment, reduction of the negative pressure in the nasalairway can be effected to reduce collapse of the structures of the nasalairway on inspiration without changing a shape of the nasal valve. Forexample, this may be accomplished by creating an air passage that allowsflow of air directly into the site of negative pressure. One example ofthis is creating a hole through the lateral wall of the nose allowingairflow from the exterior of the nose through the nasal wall and intothe nasal airway.

In another embodiment, energy, mechanical or chemical therapy may beapplied to the tissue of the nasal airway with the express purpose ofchanging the properties of the extracellular matrix components toachieve a desired effect without damaging the chondrocytes or othercells of the nasal airway tissue.

In some embodiments, devices (e.g., devices like those described withrespect to FIGS. 9A-21B) may be used to provide tissuere-shaping/molding and to impart energy to the nasal valve. Theelectrode may be placed in contact with the target nasal valve tissue.The electrodes and molds may be moved to shape the tissue as necessaryto achieve improvement in nasal airway. The electrodes may be activatedwhile the tissue is deformed in the new shape to treat the tissue. Theelectrode may then be deactivated and the device may be removed from thenasal valve area.

FIGS. 30A-30D depict a method for using a device 800 similar to thosedevices described above, including but not limited to FIGS. 8A, 9B, 18,22A-G, and 23A-G, to provide tissue re-shaping/molding and to impartenergy to tissue near the nasal valve.

The method may include identifying a patient who desires to improve theairflow through their nasal passageways and/or who may benefit from anincrease in a cross-sectional area of the opening of the nasal valve.The patient may be positioned either in an upright position (e.g.,seated or standing) or be lying down. Local anesthesia may be applied toan area near or surrounding the tissue to be treated. General anesthesiamay also be used.

Optionally, a positioning element, like that described herein, may beused to measure a desired depth or angle of treatment. As describedabove, the positioning element may be inserted to the desired depth oftreatment and rotated to a desired angle of treatment. Marks along thepositioning element can indicate the desired depth. Marks along the baseof the shaft of the positioning element can indicate the desired angle.The physician or other medical professional administering the treatmentcan then insert the treatment device to the desired location. Thephysician may also assess any other characteristics relevant to thetreatment of the patient's nose that may influence the manner oftreatment. In some embodiments, a re-shaping element may be used tomanipulate the nasal tissue into a configuration allowing improvedairflow; and treatment may be performed while such a re-shaping elementis maintaining the desired configuration of the nasal tissue.

If the treatment device comprises a monopolar electrode or electrodeneedles, a ground pad may be attached to the patient. The ground pad maybe attached at the patient's torso, for example the shoulder or abdomen.Other locations are also possible, such as the patient's buttocks.Preferably, the point of attachment is a large, fleshy area. After beingattached, the ground pad may be plugged into a power source. If thedevice is powered by a remote generator (e.g., RF generator), the devicemay then be plugged into the generator.

FIG. 30A depicts the nose of a patient prior to insertion of the device.As shown in FIG. 30B, the device is then inserted into a nostril of thepatient. The treatment element 802 of the device 800 may be positionedwithin the nasal airway, adjacent to nasal tissue (e.g., upper lateralcartilage) to be treated. The treatment element 802 may be positioned sothat the electrode is in contact with the tissue to be treated. Thedevice 800 (as shown in FIG. 30C) comprises multiple needle electrodes804. The needle electrodes 804 may be inserted so that they arepenetrating or engaging tissue to be treated.

The treatment element 802 may be used to deform the nasal tissue into adesired shape by pressing a convex surface of the treatment element 802against the nasal tissue to be treated. FIG. 30C shows an internal view,from the nares, of the treatment element 802 pushing against the upperlateral cartilage 806 of the nose, deforming the upper lateral cartilage806 and increasing the area of the opening of the nasal valve 808. FIG.30D depicts an external view of the treatment element 802 deforming theupper lateral cartilage 806. Even from the outside, the nose appears tobe bulging near the area to be treated. In some embodiments, thedeformation required to treat the nose is not visually detectable. Acontrol input such as button 814 may be used to activate the electrodeand deliver energy (e.g., RF energy) to the tissue to be treated.

In some embodiments, temperature of the area around the electrode duringtreating is from about 30 degrees Celsius to about 90 degrees Celsius.In some embodiments, temperature of the area around the electrode duringtreating is from about 40 degrees Celsius to about 80 degrees Celsius.In some embodiments, temperature of the area around the electrode duringtreating is from about 50 degrees Celsius to about 70 degrees Celsius.In some embodiments, temperature of the area around the electrode duringtreating is about 60 degrees Celsius. In some embodiments, for exampleduring cryo-therapy, temperature of the area around the electrode may belower.

In some embodiments, treating the target tissue comprises treatment forabout is to about 3 minutes. In some embodiments, treating the targettissue comprises treatment for about 10 s to about 2 minutes. In someembodiments, treating the target tissue comprises treatment for about 15s to about 1 minute. In some embodiments, treating the target tissuecomprises treatment for about 20 s to about 45 s. In some embodiments,treating the target tissue comprises treatment for about 30 s.

In some embodiments, treating the target tissue comprises deliveringbetween about 1 and about 100 watts to the tissue. In some embodiments,treating the target tissue comprises delivering between about 5 andabout 75 watts to the tissue. In some embodiments, treating the targettissue comprises delivering between about 10 and about 50 watts to thetissue.

As shown in FIGS. 30B and 30D, a thermocouple 812 may be provided on theelectrode (e.g., as described with reference to FIGS. 22G and 27). Insome embodiments, more than one thermocouple may be provided. Forexample, in embodiments comprising more than one electrode or electrodepair, each electrode or electrode pair may comprise a thermocouple. Thethermocouple 812 may monitor temperature of the electrode and providefeedback to a control unit (e.g., control system 42 described withrespect to FIG. 3). The control unit may use the data from thethermocouple 812 to regulate temperature and auto-shutoff once treatmenthas been achieved or in the case of an overly high temperature.

After treating the tissue, the device 800 may be removed from thenostril. If a grounding pad is used, the grounding pad may be detachedfrom the patient.

In some embodiments, differential cooling mechanisms may be used totreat the nasal valve using electrodes or other energy delivery elementswhile maintaining a reduced temperature at the skin and/or mucosa. Forexample, devices like those described with respect to FIGS. 25A-27 ordevices employing the differential cooling mechanisms described withrespect to FIGS. 28A-28E may be used. The cooling system may beactivated. The device may then be inserted into the nose and placed incontact with the nasal vale. The device may then be activated.Activation of the device may cause an increase in the cartilagetemperature while minimizing the temperature increase in the skin and/ormucosa. The device may then be deactivated and removed from the nose.

In some embodiments, devices may be used in which insulating material isused to protect non-target tissue during energy delivery. In anembodiment, a device comprises an electrode needle preferentiallyinsulated on a portion of the needle. The needle may be inserted intothe cartilage so that the insulated portion is in contact with themucosa and/or the skin and the non-insulated portion is in contact withthe cartilage. The device may be activated, causing an increase in thecartilage temperature while minimizing temperature increase in the skinand/or mucosa. The device may be deactivated and removed from the nose.

Additional Embodiments and Optional Features

Referring now to FIGS. 31A and 31B, in one embodiment, a device 900 fortreating a nasal valve may include an internal power source and thus becordless. In the embodiment shown, the device 900 includes a handle 902coupled with a shaft 904, which in turn is coupled with a treatmentelement 908. The handle 902 may include a power button 910 (or “on/offswitch”), a circuit board (912, FIG. 31B) and a space and connectionsfor insertion of batteries 914 as a power source. Treatment element 904may include multiple needle electrodes 906 for applying RF energy totissue.

Any suitable features, elements, materials or the like that have beendescribed above may be applied to the device 900 in a similar way. Invarious alternative embodiments, the device 900 may include any number,size or type of batteries, depending on the size of the handle 902 andpower requirements of the device 900. In some alternative embodiments,the device 900 may include an alternative power source. For example, thebatteries 914 may be rechargeable in some embodiments. In otherembodiments, it may be possible to plug the device 900 into a powergenerator for charging, and then unplug the device 900 for use. In yetother alternative embodiments, the device 900 may include a solar powercollection member. The advantage of including an internal power sourcein the device 900 is that this eliminates the need for the device 900 tobe connected, via power cord, to a large, table-top generator, as mostenergy delivery surgical/medical devices require. This allows aphysician to perform a nasal valve procedure in any location or patientorientation without having to manage power cables and generators.

Referring now to FIGS. 32A and 32B, in some embodiments, a system fortreating a nasal valve may include one or more sensors. Such sensors maybe used to sense any of a number of relevant tissue properties, such astemperature, impedance and the like. The sensors may be located on atreatment device in some embodiments, or alternatively they may beseparate from the treatment device and positioned at or near the deviceduring treatment. In some embodiments, the sensor(s) may providefeedback directly to the treatment device. For example if a particulartissue temperature threshold is reached, a sensor (or sensors) may senda signal to a power generator to shut down or decrease power deliveredto a treatment device. In alternative embodiment, the sensor(s) mayinstead provide feedback to a physician or other user, so that thephysician or other user can make treatment adjustments. For example,sensors may provide a warning signal when a particular tissuetemperature or impedance is reached, which will help a physician knowwhen to turn off or decrease power delivery to a treatment device.Additionally, sensor(s) may be used to sense one or more tissueproperties in any suitable tissue or multiple tissues, such as but notlimited to mucosa, cartilage, dermis, epidermis and other types of bodysoft tissue.

FIG. 32A illustrates nasal skin in cross section, including mucosa,cartilage, dermis and epidermis. In one embodiment, a sensor device 920may include an epidermal sensor 922 that is coupled to the epidermis viaan adhesive 924. Any suitable sensor 922 (temperature, impedance, etc.)and any suitable adhesive 924 may be used. This embodiment of the sensordevice 920 is also illustrated on a patient's face in FIG. 32B.

In an alternative embodiment, a sensor device 930 may include atransdermal needle sensor 932. In another alternative embodiment, asensor device 942 may be attached directly to a treatment device 940. Asillustrated by these various embodiments, sensors 922, 932 and 942 maybe positioned either at or near a treatment location during a treatment.In some embodiments, for example, a sensor 922, 932 may be placed on orin epidermis while a treatment is being performed on mucosa.Alternatively, a sensor 942 may be placed directly on mucosa during atreatment of mucosa. Additionally, in any given embodiment, multiplesensors may be placed at multiple different locations in and/or ontissue. As mentioned above, the sensor devices 920, 930 and 940 may, invarious embodiments, provide any of a number of different types offeedback, such as feedback to a user, feedback to a power generator, orboth.

Referring now to FIGS. 33A and 33B, in some embodiments, a treatmentdevice 950 may include a treatment element 952 with wings 954 extendinglaterally from it. The wings 954 are configured to help direct thetreatment element 952 into a particular treatment location/positionand/or to prevent the treatment element 952 from contacting tissue thatthe physician does not want to treat. For example, FIG. 33B illustratesa top, cross-sectional view of a nose N, showing the lateral wall LW,nasal septum S and an intersection I between the lateral wall LW andnasal septum S. In many or most cases, it may be undesirable to treatmucosa at the intersection I with RF energy or other energy delivery orremoval devices. The wings 954 will help prevent the treatment element952 from being advanced far enough toward the intersection I to actuallycontact and treat that mucosa. Alternative embodiments may includeadditional wings or other protrusions or shapes to prevent contact withthe intersection I and/or other structures. Some embodiments may includeadjustable wings or wings that expand once the electrodes have beenplaced. Any other size, shape or configuration of one of more wings maybe included, according to various embodiments.

Referring to FIGS. 34A-34C, in various alternative embodiments,treatment elements of nasal valve treatment devices may have differentshapes and/or sizes for addressing different types and/or shapes oftissue. For example, as shown in FIG. 34A, in one embodiment, atreatment element 960 of a device may have a square or rectangularprofile with a flat distal end, which may be ideal for addressingrelatively flat tissue configurations. Two electrodes 962 (or two setsof electrodes) may be used to send an arc of current (e.g., RF current)through tissue in the pattern shown by the multi-headed arrow.

In another embodiment, as shown in FIG. 34B, a treatment element 970 mayhave an oval profile with a curved distal end. Two electrodes 972 orsets of electrodes send a current through tissue in an arc. Thisconfiguration may be advantageous for addressing tissue having a curvedprofile. In yet another embodiment, as shown in FIG. 34C, a treatmentelement 980 may have a flatter curved profile, for example foraddressing tissue with a curved shape but not as sharp of an angle asthe tissue shown in FIG. 34B. Again, the electrodes 982 send energythrough the curved tissue in a curved arc.

As is evident from FIGS. 34A-34C, a treatment element of a treatmentdevice may have any suitable configuration for advantageously addressingany tissue type and shape. In some embodiments, multiple differenttreatment devices, each having a differently shaped treatment element,may be provided, and a user may select a treatment device for aparticular tissue type and/or shape, based at least in part on the shapeof the treatment element of the device.

Referring to FIG. 35, in another embodiment, a treatment device 1000 fortreating a nasal valve and/or tissues near the nasal valve may includean expandable member 1002, such as but not limited to an expandablepolymeric balloon. For example, a non-compliant or semi-compliantballoon may be used in some embodiments to expand tissues in and/oraround the nasal valve, to achieve one or more of the effects discussedabove in relation to the various embodiments. Although expandableballoon devices (e.g., balloon catheters) have been described previouslyfor use in expanding ostia (openings) of the sinus cavities, they havenot been described for use in changing the shape and/or physicalcharacteristics of the nasal valve. In various method embodiments, theexpandable member 1002 may be positioned at any of a number of suitablelocations at or near a nasal valve and then expanded to deform tissuesthat make up the nasal valve. In some cases, these tissues may be atleast partially deformed permanently or at least for a period of timeafter the procedure. In other cases, the tissue may only be deformedduring the procedure, but one or more properties of the tissue may beaffected by the balloon expansion.

In various alternative embodiments, a treatment device for nasal valvetissue and/or other nasal tissue may use a treatment modality that doesnot involve delivery of energy to, or removal of energy from, tissue.For example, in some embodiments, the treatment device may create somekind of mechanical injury to one or more tissues to cause a change inshape and/or one or more properties of the tissue. The expandableballoon embodiment described above is one example. Other examples mayinclude, but are not limited to, needles, micro-needles, blades or thelike, any of which may be used to cause scar tissue formation and/ortissue contraction. Other embodiments may use sclerotherapy, involvinginjecting one or more substances (acid, coagulants, etc.) into thetarget tissue to induce scar tissue formation and/or other changes inthe tissue properties. In some cases, one type of tissue (for example,mucosa) may be transformed into a different type of tissue altogether(for example, scar tissue). In other examples, a one or more propertiesof the tissue may be changed without changing the overall type oftissue. For example, the tissue may be caused to shrink, contract,stiffen and/or the like. One advantage of these non-energy-basedembodiments is that they do not require a source of energy. This maymake them easier to use and possibly to manufacture and supply.

In other embodiments, thermal energy may be applied to the nasal valveby applying the energy from an external location on the nose, ratherthan an internal location within the nasal cavity. For example, in someembodiments, a treatment device may be positioned on the nose and usedto deliver thermal energy through the epidermis to the deep subdermaland/or dermal layer above the nasal valve. In some embodiments, thetreatment device may also be used to cool the superficial dermis andepidermis, for example. This delivery of energy could, in someembodiments, act to tighten tissues of the nasal valve, thus preventingcollapse during breathing. In an alternative embodiment, instead ofusing thermal energy to change the tissues, a treatment device may usemechanical means, such as micro-needles, to create a subdermal tissueresponse, such as scarring, for a similar type of tissue tighteningeffect.

In yet other embodiments, some methods for treating a nasal valve mayinclude applying a gel, paste, liquid or similar substance to a surfaceof the nose during an energy delivery treatment of the nasal valve. Suchsubstances may be applied to target tissue, such as mucosa, non-targettissue, such as epidermis, or a combination of both. The substance (orsubstances) applied may serve any of a number of different purposes,such as but not limited to modifying conductivity of tissue andproviding anesthetic effect. Conductivity enhancing substances mayimprove the efficiency and/or consistency of energy delivery (such asbut not limited to RF energy). Alternatively or additionally, one ormore substances may be injected into tissue. For example, saline,Lidocaine, other anesthetic agents, or any other suitable agents, may beinjected. Some embodiments may involve applying one substance andinjecting another sub stance.

In other alternative embodiments, it may be possible to achieve desiredchanges in tissue properties and/or shapes by injecting substance orapplying substance only—in other words, without also applying energy.For example, injecting a sclerotherapy substance into tissue may, insome embodiments, achieve a desired tissue result. In additionalalternative embodiments, a method of treating a nasal valve may includeinjecting a substance into nasal tissue and then curing the substance inorder to change the substance's properties and, in turn, at least one ofthe nasal tissue's properties. A treatment device may be used to curethe substance. In some embodiments, the treatment device may be used todeform the target tissue and cure the substance, while the tissue isdeformed, so that the tissue retains approximately the same, deformedshape after the substance is cured and the treatment device is removed.In another alternative embodiment, a surface-based biodegradable agentmay be applied and cured to change the shape of the target nasal tissue.

Referring now to FIG. 36, any of the embodiments discussed above may beused to treat tissue that is considered part of the nasal valve, tissuethat is immediately adjacent or near nasal valve tissue, tissue fartheraway from the nasal valve that affects nasal valve function, or somecombination thereof. FIG. 36 is a diagrammatic illustration of theinternal nasal valve. As mentioned previously, the internal nasal valve,which accounts for the larger part of the nasal resistance, is formed bythe nasal septum S, the caudal border of the upper lateral cartilage(ULC), the head of the inferior turbinate, and the pyriform aperture Pand the tissues that surround it. In FIG. 36, the triangularrepresentation is comprised of the septum S, the pyrifom aperture P, andthe lateral wall LW. According to various embodiments, any area withinthe triangle, immediately outside the triangle, or even more distantfrom the triangle, may be treated, in order to affect function of thenasal valve. In one embodiment, for example, a treatment area 1010 maybe located at a juncture of the pyriform aperture P and the lateral wallLW, and in various embodiments the treatment area 1010 may be locatedentirely within the triangle or may extend outside of it. This is butone example of an area that may be treated, according to variousembodiments.

One mechanism of action that may be involved in any of the embodimentsdescribed above may be to reduce mucus production and/or accumulation inand/or around any treated areas. Although emphasis has been placed onstructure and function of the nasal valve in much of the foregoingdescription, mucus reduction may also be part the beneficial result ofany treatment, in some embodiments.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

What is claimed is:
 1. A device for treating a nasal airway by modifyinga property of a nasal tissue of or near a nasal valve of the airway,without using a surgical incision or an implant, to decrease airflowresistance or perceived airflow resistance in the nasal airway, thedevice comprising: a handle; an elongate shaft extending from a firstend of the handle; and a treatment element extending from a second endof the elongate shaft that is opposite the first end, wherein thetreatment element is sized to be inserted into a nostril and configuredto at least temporarily deform the nasal tissue and deliverradiofrequency energy to modify the property of the nasal tissue, andwherein the treatment element comprises: a front, tissue contact surfacehaving a convex shape configured to at least temporarily deform thenasal tissue into a concave shape; a back surface; and a monopolarradiofrequency electrode disposed on the tissue contact surface of thetreatment element.